Posts Tagged ‘Food & Drug Administration’

8:20AM 11/12/2014 – 10th Annual Personalized Medicine Conference at the Harvard Medical School, Boston

Reporter: Aviva Lev-Ari, PhD, RN


REAL TIME Coverage of the Conference by Dr. Aviva Lev-Ari, PhD, RN – Director and Founder of LEADERS in PHARMACEUTICAL BUSINESS INTELLIGENCE, Boston http://pharmaceuticalintelligence.com


8:20 a.m. Special Guest Keynote Speaker – The Future of Personalized Medicine

The Future of Personalized Medicine

Special Guest Speaker

Margaret Hamburg, M.D.
Commissioner of Food and Drugs Administration

[Her Father was President of IOM said at the introduction to the Keynote]

How to ask the right question is what HMS taught me best 

Increasing the knowledge of Biology, response to disease, preventive strategies.

2004 — Monumental year — One year after completion of sequencing the Genome

2008/9 – Breast Cancer – pharmacotherapy approved, a protein involved in triggering the disease.Target therapy – risk of disease identified

WHAT FDA is doing on Genetics Information as PARTNERS in Medicine

25% of drugs approved are Targeted therapies

LABELING drugs on genetic information

diagnostics test — identify good respondents

Companion Diagnostics – should be used in Targeted therapies. IGF1, HER2 expression and amplification

PM more important in ONCOLOGY , HepB, Cystic Fibrosis, differential response, CVD – expansion, more to be done

In 2002 — a Program to discuss Genetic information VSDS – New Genomics Program, National Center for Toxicology Research a participants

Translational Scientist are added.

Completion Genome sequencing — push to PM 2011 – Genomics evaluation Team for Safety.

Challenge – Drug, Biologics – interaction need coordination by Agency to discuss challenges and collaboration with out side Group.

Developers of Targeted therapies: Orphan Drugs, Biomarkers – expedited review to promote innovations, fast track breakthrough therapies. Opportunities of Scientist to engage discussion with FDA

 – ALL hands on Deck Approach at FDA – making products available, i.e. SCLC (small cell lung cancer)

Since 2005 – 25 Guidance Reports, i.e., Orphan Drugs and on Companion Diagnostics to be developed in tandem with drug development.

Companion Diagnostics – 3 month review, enforcement and direction – in the framework

FDA — needs to keep up with development in the Diagnostics and in the disease ares.

Illumina – Assays using SNIPS – FDA assesses a shared curated DB on mutation, reduce the review time significantly

FDA – NGS – reference libraries, Genomics Reference and Storage of genomics data

Tools and Capabilities  – support regulatory and science, statistical methods of analysis — implemented for Breast Cancer — signaled the way of new Partnerships and New Clinical Trials formats and methods in its development.

New diagnostics – AMP Program Alzheimer’s Disease, rheumatoid arthritis (RA), inflammatory bowel syndrome (IBS)

What Science is needed for the Regulators to effectively HELP spar innovation.

Pharmacogenomics, Pharmacogenetics — MAPPING the Human Genome and all other areas of “OMICS” – moving from Lab to bedside — requires expertise in Disease prevention, Difference in patients life, Standard medical practice

  • Biology and Pathways
  • Biomarkers
  • New diagnostics
  • Increased communication Universities, new paradigms models and continual effort of SHARING and coordination of shared resources


– See more at: http://personalizedmedicine.partners.org/Education/Personalized-Medicine-Conference/Program.aspx#sthash.qGbGZXXf.dpuf





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Reporter: Aviva Lev-Ari, PhD, RN

BIOMEDevice Boston Conference 2013
April 10-11 2013, Boston, MA


New conference format for 2013…

Don’t miss out on 2013’s new and improved BIOMEDevice Boston Conference.

Choose from six seminar sessions across the two day conference that will deliver crucial insights and guidance on biomedical regulations, design engineering, new biomaterial innovations and product development for the medical device industry.

Six Solution Packed Seminars

April 10, 2013 April 11, 2013
10:00-11:45am Seminar 1
Advanced Technology and Device Innovation
Seminar 4
Accelerating Speed to Market 
1:00-2:45pm Seminar 2
Intelligent Design for Implantable Devices
Seminar 5
FDA Regulatory Guidance and Updates
3:15-5:00pm Seminar 3
New Innovations in Drug Device Combination Products
Seminar 6
Human Factors: Enhancing Usability and Managing Risk

Conference Speakers

Jay Crowley, Senior Advisor Patient Safety, FDA

Jay Crowley is Senior Advisor for Patient Safety, in FDA’s Center for Devices and Radiological Health. He is interested in developing and implementing new methods and techniques for identifying and resolving problems with the use of medical devices. Jay has held variety of positions over his 25 years at FDA. Currently, Jay has responsibility for implementing the Unique Device Identification requirements of the 2007 FDA Amendments Act and 2012 FDA Safety and Innovation Act. He holds a master’s degree in risk analysis and a bachelor’s degree in mechanical engineering.

Emmanuel Nyakako
, Senior VP of Global Quality & Regulatory Affairs, Zimmer Inc


Matthew Myers, PhD, Research Physicist, FDA 

Matthew R. Myers received his doctorate in Applied Mathematics from the University of Arizona. He worked in the research and development laboratory of Corning Glass Works, where he performed mathematical modeling of fiber drawing and other processes involving molten glass. Dr. Myers was later employed as an acoustics consultant with BBN Systems and Technologies. In 1990, Dr. Myers joined the Center for Devices and Radiological Health of the U. S. FDA. He has performed mathematical modeling in the areas of drug delivery, cardiovascular implants, virus transport, and most recently, therapeutic ultrasound. His current research areas include noninvasive methods for pre-clinical testing of focused-ultrasound surgery devices, and modeling of debris retention in reusable medical devices. Dr. Myers also performs consulting reviews on device submissions involving fluid flow and acoustic wave propagation, most recently applications to treat Parkinson’s disease and Essential Tremor with therapeutic ultrasound.

Dr. Thomas J Webster, Associate Professor, Divisions of Engineering and Orthopaedic Surgery, Brown University 

Thomas J. Webster’s degrees are in chemical engineering from the University of Pittsburgh (B.S., 1995) and in biomedical engineering from Rensselaer Polytechnic Institute (M.S., 1997; Ph.D., 2000). He is currently the Department Chair and Professor of Chemical Engineering at Northeastern University in Boston. He has graduated/supervised over 109 visiting faculty, clinical fellows, post-doctoral students, and thesis completing B.S., M.S., and Ph.D. students. To date, his lab group has generated over 9 textbooks, 48 book chapters, 306 invited presentations, at least 403 peer-reviewed literature articles, at least 567 conference presentations, and 32 provisional or full patents. His H index is 47. Some of these patents led to the formation of 9 companies. He has received numerous honors including, but not limited to: 2002, Biomedical Engineering Society Rita Schaffer Young Investigator Award; 2005, Coulter Foundation Young Investigator Award; 2011, Oustanding Leadership Award for the Biomedical Engineering Society (BMES); and Fellow, American Institute for Medical and Biological Engineering.

John (Barr) Weiner, Associate Director of Policy, Office of Combination Products, FDA 

John Barlow Weiner is the Associate Director for Policy in the Food and Drug Administration’s Office of Combination Products, which is tasked with the classification and assignment for regulation of therapeutic products (drugs, devices, biological products, and combination products), and with ensuring the sound and consistent regulation of combination products. Prior to joining OCP, Mr. Weiner was an Associate Chief Counsel in FDA’s Office of Chief Counsel, advising the agency on various issues including regulation of drugs and cross-cutting topics including the regulation of products that use nanotechnology. Before coming to FDA, Mr. Weiner was in private practice in the areas of food and drug, environmental, and related aspects of public international and trade law. He has published and lectured on topics in all three areas. Mr. Weiner received a BA from Princeton University and a JD with honors from the Columbia University School of Law.

Olivia Hecht
, Senior Marketing Manager, Wireless & Networking, Philips Healthcare

Olivia Hecht is currently Sr. Manager of Technology and Platforms Integration, for Philips Healthcare Patient Care and Clinical Informatics. She came to the healthcare industry with over 20 years in the information technology sector working in product management and product marketing for companies such as Bay Networks, an early innovator in network infrastructure; RSA Security, a leader in enterprise security; and Legra Systems, a start up manufacturer of enterprise Wi-Fi equipment. She has a Masters degree from the Massachusetts Institute of Technology and Bachelor of Science in Biology.

Joel Kent, Regulatory Affairs Manager, GE Healthcare 

Joel Kent, RAC (Canada, EU and US) is currently Manager, Regulatory Affairs for GE Healthcare, Healthcare Systems Patient Care Solutions business. He has 18 years experience in regulatory affairs covering a variety of medical devices. He holds a Bachelor of Science degree in Electrical and Biomedical Engineering from Duke University and a Master of Science in Biomedical Engineering, Worcester Polytechnic Institute. Mr. Kent has nine publications related to pulse oximetry and gastric tonometry and has been granted two US and Japanese Patents for Remote Sensing Tonometric Catheter Apparatus and Method. He is a lecturer at Northeastern University, Boston, MA and is an IEEE Senior Member and American Society for Quality (ASQ) Senior Member. In addition, he is a Regulatory Affairs Professional Society (RAPS) member serving as Vice-Chair of the RAPS Boston Chapter and member of the RAPS 2008-2011 Annual Conference Committee and RAPS Annual Conference Preconference workshop committee on Latin America Medical Device Regulations in 2012. Speaking engagements have included the RAPS Annual Conferences, Medical Devices Summit East 2011, 2012 and 2013 and the 11th annual AdvaMed Emerging Growth Company Council conference.

Pat Baird, Product Design Owner, Baxter Healthcare

Pat Baird is a Product Design Owner at Baxter Healthcare, with oversight responsibility for over $400M in installed medical devices. His previous roles included software developer, function manager, program manager, and engineering department manager. Drawing on 20 years’ experience in product development, he has published and presented over 30 papers on topics such as software development, change management, stakeholder management, and risk management. He is currently the co-chair of the AAMI Infusion Pump Standards committee, chair of the Assurance Case Technical Information Report Working Group, a US representative to the IEC standards committee, founder of the Infusion Systems Safety Council and the Coalition of Organizations Reporting Adverse Events. He has earned multiple industry awards for his work to advance patient safety. He recently completed a Masters in Healthcare Quality and Patient Safety at Northwestern University in Chicago.

Dr. Eric Ledet, Associate Professor, Rensselaer Polytechnic Institute

Eric Ledet is an Associate Professor in the Department of Biomedical Engineering at Rensselaer Polytechnic Institute where he has taught medical device design and maintained an active research program in orthopaedic biomechanics for the last 9 years. Prior to joining RPI, he served as Director of the Orthopaedic Research Program at the Albany Medical College for 9 years. He has served as a consultant to medical device companies for 15 years and is currently principal partner in three medical device startup companies. He earned a bachelor’s degree in mechanical engineering from the University of Arizona and a Master of Science and doctorate in biomedical engineering from Rensselaer Polytechnic Institute.

Judith K Meritz, Associate General Counsel, Covidien

Jeffrey Morang
, Human Factors Engineer and User Experience Analyst, Siemens Healthcare Diagnostics

Jeffrey Morang is a Human Factors Engineer for the Point of Care line of instruments at Siemens Healthcare Diagnostics. Jeff received his MS in Human Factors and Ergonomics from San Jose State University. Jeff has experience as a researcher in aeronautical human factors, focusing on human perceptual and cognitive performance, for the Virtual Airspace Modeling and Simulation Project at the NASA Ames Research Center. After graduation, he joined Future Combat Systems project at British Aerospace Systems responsible for mapping soldier roles and assessing their cognitive and physical workloads using real-time usability testing methods. Jeff has brought that expertise to his current position at Siemens where his team is responsible for employing a synergistic design and testing methodology on behalf of a variety of end users in the relatively new area of healthcare called Point of Care.

George Papandreou, VP Quality, Lutonix, CR Bard 

George Papandreou, Ph.D., is Vice President of Quality at Lutonix, a subsidiary of C.R. Bard. In his current position, George is working on drug-coated balloons for the treatment of peripheral artery disease. George has extensive experience in formulation, analytical characterization and process development. He has a proven record in the commercialization of advanced drug delivery concepts, such as drug/device combination products, and has contributed in the approval of novel therapeutic solutions, such as the CYPHER® Sirolimus-eluting Coronary Stent. He has defined the strategy to address Chemistry Manufacturing and Controls issues, and has significant expertise in troubleshooting complex technical and quality issues during research, development and manufacturing of drug products. George has earned a Ph.D. in organic chemistry, and has co-authored of over 35 publications, as well as applied and issued patents.

Eric Roden
, Associate Director, Operational Excellence, B. Braun Medical 

Marjorie Shulman
, Director, 510(K) Premarket Notification Staff, FDA

Rahul Sapreshker, Associate Professor- Electrical Engineering & Computer Science, MIT

Roger Narayan, Professor, Biomedical Engineering, North Carolina State University

Dr. Roger Narayan is a Professor in the Joint Department of Biomedical Engineering at the University of North Carolina and North Carolina State University. He is an author of over one hundred publications as well as several book chapters on processing and characterization of biomedical materials. He currently serves as an editorial board member for several academic journals, including as editor-in-chief of Materials Science and Engineering C: Materials for Biological Applications (Elsevier). Dr. Narayan has been elected as Fellow of ASM International, AAAS, and AIMBE.




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FDA: Strengthening Our National System for Medical Device Post-market Surveillance

Reporter: Aviva Lev-Ari, PhD, RN


September 7, 2012 | By Damian Garde

The FDA wants industry feedback on a host of new post-market surveillance initiatives, designed to better track, analyze and report the performance of medical devices.

In a report released Thursday, the agency proposes a four-point plan to improve its post-market system, including the previously announced unique ID program and a modernization of MedWatch. The agency is taking any and all opinions from devicemakers and members of the healthcare community through its website, and the FDA plans to host public meetings on the plan this month.


Here’s a summary of the four points:


Establish a unique device ID system: In keeping with its July announcement, the FDA wants to require devicemakers to tag their products with an alphanumeric code, disclosing the device’s production information, serial number, manufacturing date and expiration date. The goal is to help the FDA and healthcare community to more accurately track and analyze device-related adverse events. Once rolled out, the ID system will cost the industry $65 million, the FDA has said.

Promote international device registries: The agency isn’t looking to found a huge, centralized registry, housing data on device uses and reactions. Instead, the FDA wants to help governments and private outfits set up and operationalize smaller registries, sharing data with one another to keep tabs on device performance. The agency plans to host a series of public workshops to educate would-be registry founders on the best way to move forward.

Modernize adverse event reporting: Currently, the FDA relies on spontaneous reporting for when devices go awry, primarily using its voluntary MedWatch system. That model is inherently limited, the agency says, and it wants to institute automated reporting systems in hospitals, encourage more electronic reporting, develop a mobile app for MedWatch and update the MAUDE adverse event database, which the FDA says is technologically outdated.

Develop new tools and methods for post-market surveillance: This is the catch-all part of the FDA’s plan, in which the agency discusses future innovations that could generate, synthesize and interpret post-market data to drive decision-making. For instance, the FDA wants to automate data analysis to identify spikes in adverse events across disparate data sources. The agency also proposes instituting quantitative decision analysis in its post-market deliberations, aiming to better standardize its methods.




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Reporter; Aviva Lev-Ari, PhD, RN

October 1, 2012 by MassDevice staff

More turnover at Stryker as the orthopedics giant names Kevin Lobo, former head of the orthopedics division, its new president & CEO.

Updated October 1, 2012 at 1:20 p.m. with comments from Stryker.

Stryker CEO Kevin Lobo

There was more turnover at orthopedics giant Stryker (NYSE:SYK) as the company pulled from its own ranks to name Kevin Lobo its new president & CEO.

Lobo replaces interim CEO Curt Hartman, who is leaving the company after a transitional period, the Wall Street Journalreported. Hartman was also CFO for the company, a role he held since April 2009.

“After a very thorough search process involving external and internal candidates, we are pleased to name Kevin Lobo as Stryker’s president and chief executive officer,” Stryker non-executive board chairman William Parfet said in prepared remarks. “Since joining Stryker in 2011 he has proven to be a highly effective leader for our Orthopedics Group, and he has won the confidence of employees, customers and the Board.”





“Mr. Lobo joined Stryker in April 2011 and most recently served as group president, orthopedics,” according to Lobo’s executive bio. “Prior to joining Stryker, Mr. Lobo served in several senior leadership roles at Johnson & Johnson (NYSE:JNJ), including as worldwide president of Ethicon Endo-Surgery.”

Not Having 510(k) Clearance, FDA Recall advised and Patient to Return Certificate of Medical Necessity form to Stryker by Oct. 2012: Neptune Rover Waste Management System in the United States, Asia Pacific, Canada, Japan, Latin America and EMEA. Following recall of  Hip Implant Recall by Stryker Orthopaedics Rejuvenate Modular Hip Systems in July 2012.

Urgent Medical Device Recall – Stryker Issues Class 1 Recall of Neptune Rover Waste Management System in the United States, Asia Pacific, Canada, Japan, Latin America and EMEA
KALAMAZOO, Mich., Sept. 25, 2012  /PRNewswire/ — On June 5, 2012, Stryker initiated a Class 1 recall of the Neptune Waste Management System. The devices are being recalled because Stryker has received two reports of serious injury as a result of tissue damage associated with the use of the Neptune 2, including an event in which one customer connected the Neptune 2 System to a passive chest drainage tube post operatively, resulting in a fatality.

The recall includes all serial numbers for the following model numbers:

Product Name Catalog Number Manufacture Dates Distribution Dates IFU Part Number
Neptune 1 Gold Rover 0700-001-000 1/11/01 – 12/23/09 3/26/01 – 1/30/10 0700-001-700
Neptune 1 Gold Rover – International 0700-002-000 9/15/05 10/3/05 – 10/3/05 0700-002-707
Neptune 1 Silver Rover 0700-003-000 1/31/02 – 9/3/09 5/31/02 – 11/19/09 0700-001-700
Neptune Bronze 0700-007-000 3/22/04 – 2/22/12 3/31/04 – 6/27/12 0700-007-720
Neptune 2 Rover Ultra (120 V) 0702-001-000 12/3/07 – 8/1/12 12/31/07 – 8/7/12 0702-002-700
Neptune 2 Rover Ultra (230 V) 0702-002-000 10/9/08 – 6/18/12 3/5/09 – 7/26/12 0702-002-700

On June 5, 2012, Stryker notified customers that it was recalling the IFUs for the above products. The current IFU did not specifically warn against connecting the Neptune Rover, which is a high vacuum/high flow device, to a passive drainage tube. Customers were instructed to review the revised IFU, distribute to affected departments, and educate users of the Neptune on this warning.  Customers must confirm with Stryker via business reply form that they have completed these actions.

Customers who have the Neptune 1 Gold, Neptune 1 Gold International or Neptune 1 Bronze will receive a follow up mailing in October containing warning labels for the device and instructions detailing how to apply them.  Customers may continue to use the Neptune 1 Gold, Neptune 1 Gold International, and the Neptune 1 Bronze.  Users must be aware of the warning that was added to each device.

On September 18, 2012, Stryker notified customers via letter delivered by FedEx overnight delivery that it is expanding the recall on the Neptune 1 Silver, Neptune 2 Ultra (120V) and Neptune 2 Ultra (230V)  because FDA has also advised Stryker that these devices require, but do not currently have, 510(k) clearance. FDA is therefore unable to determine whether these devices are as safe and effective as their legally marketed predicate, the Neptune 1 (Gold) Waste Management System (510(k) K012992).  As such, Stryker has ceased distribution of the Neptune Silver, Neptune 2 Ultra (120V) and Neptune 2 Ultra (230V) devices until FDA clears these devices.

At this time, FDA does not consider the Neptune Silver, the Neptune 2 Ultra (120V) or the Neptune 2 Ultra (230V) to be legally marketed devices because their safety and effectiveness have not yet been determined. As such, FDA advises that the devices not be used.  However, customers who do not have an alternative device to use should weigh the risks and benefits associated with continued use of these devices. If customers choose to continue use of the Neptune Silver, Neptune 2 Ultra (120V) or Neptune 2 (230V), they must complete a Certificate of Medical Necessity and return it to Stryker by October 12, 2012.

Customers who submit their signed Certificate of Medical Necessity to Stryker will receive a follow up mailing containing warning labels for the device and instructions detailing how to apply them.

Customers who have questions about this recall should contact Stryker Instruments’ Recall Coordinator, Angela Ragainis, Monday – Friday, 8am – 5pm ET, at 269-389-2316 or strykerinstrumentsrecalls@stryker.com.

Healthcare professionals and customers may report adverse events or quality problems experienced with the use of this product to Stryker by calling 1-800-253-3210 or by using the FDA’s MedWatch Adverse Event Reporting program either online athttp://www.fda.gov/Safety/MedWatch/HowToReport or by phone at 1-800-332-1088.

About Stryker

Stryker is one of the world’s leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. The Company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives. For more information about Stryker, please visit www.stryker.com.

SOURCE Stryker



NEW YORK, Sept. 25, 2012 /PRNewswire/ — Seeger Weiss LLP advises that on July 6th, 2012, Stryker issued a voluntary recall of its Rejuvenate Modular Hip System and ABG II Modular-Neck stems due to mounting evidence that its design has led to major complications in hundreds of patients. According to the Stryker press release, these implants have an increased risk of “fretting and corrosion at the modular-neck junction.”The development is the latest in a string of recalls related to hip replacement devices that utilize metal-on-metal components, which have been linked to instances of metallosis, muscle damage and complete hip implant failure.

Hip replacement surgery, otherwise known as arthroplasty, is currently one of the most commonly practiced orthopedic surgeries  in the United States, with the Agency for Healthcare Research and Quality estimating that more than 285,000 hip replacements are performed each year within the country. In an article published on December 27th, 2011, the New York Times categorized the hip replacement crisis as “the most widespread medical implant failure in decades.”

There has been a sharp rise in the number of problems associated with the use of prostheses featuring either all-metal designs or designs that contain parts that produce metal-on-metal friction. While the Stryker Rejuvenate is not a metal-on-metal hip device, it has a metal neck piece that can, under some conditions, rub against a metal stem, causing metallic debris to come loose, and in some instances, cause metallosis.

Metallosis is an adverse tissue reaction to heavy metals in the body. It can cause pain, limited mobility, failure of the hip joint, pseudo-tumors, dissolution of the bone, DNA changes and chromosomal aberrations.

The result is that injured hip replacement patients are starting to file claims against Stryker. “The abundance of evidence against the integrity of the metal-on-metal design raises serious questions as to whether Stryker practiced due diligence before releasing their product to the market,” says Chris Seeger, partner at Seeger Weiss LLP. “If it is established that Stryker put company profits ahead of patient safety, then legal action may be necessary to provide justice for those injured.”

As industry leaders with decades of experience successfully representing plaintiffs in these types of injury cases and recovering large financial awards, the partners at Seeger Weiss LLP have the expertise to provide just compensation for individuals who have suffered injuries as the result of faulty hip implants. If you or a loved one has suffered an injury due to Stryker hip replacements, visit http://www.hipimplantrecall.com/ or call 888.584.0411 for a free case evaluation.

Contact: Patricia Issacson, 212-584-0700, PIsaacson@seegerweiss.com


Stryker Recalls Neptune Devices After Death Reported

By Michelle Fay Cortez – Sep 25, 2012 4:18 PM ET

Stryker Corp. (SYK) stopped selling three versions of its Neptune Waste Management System after two people were harmed, one fatally, using the devices that were sold without formal clearance by U.S. regulators.

Stryker initiated a Class 1 recall, the most serious device withdrawal, on June 5 after two reports of serious injury from the products used to collect fluid waste during surgery, the Kalamazoo, Michigan-based company said today in a statement. In one instance, a patient’s passive chest drainage tube was hooked to the Neptune 2 System, a high-vacuum, high-flow device. The patient died, Stryker said.

The initial recall was intended to inform customers that the devices shouldn’t be connected to passive drainage tubes, a warning that wasn’t on the label. The company extended the recall on Sept. 18 to inform customers that the Neptune 1 Silver, Neptune 2 Ultra and a higher-powered Neptune 2 Ultra don’t have U.S. Food and Drug Administration approval.

The FDA doesn’t consider the devices “to be legally marketed devices because their safety and effectiveness have not yet been determined,” the company said in the statement. “As such, FDA advises that the devices not be used.”

Stryker stopped distributing the devices. Customers who don’t have an alternative machine available should weigh the risks and benefits of the recalled Neptune devices and request a certificate of medical necessity if they plan to continue using them, the company said.

Stryker fell less than 1 percent to $55.98 at the close in New York. The shares have risen 21 percent in the past 12 months.

To contact the reporter on this story: Michelle Fay Cortez in Minneapolis atmcortez@bloomberg.net

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net


Tue Sep 25, 2012 3:35pm EDT

(Reuters) – Stryker Corp said on Tuesday it expanded the recall of its Neptune surgical waste management product line to include later versions because U.S. health authorities have advised the company that these devices do not have proper regulatory clearance.

In June, the company issued a Class 1 recall, the most serious type, of its Neptune waste system after receiving two reports of serious injury and a fatality resulting from the use of the product.

The device collects surgical waste in the operating room and then disposes of the fluids without ever exposing healthcare workers to the waste.

Stryker also notified customers that it was recalling the instructions for use because they did not specifically warn against connecting the high vacuum/high flow device to a passive drainage tube.

In a press release, Stryker, a maker of hospital beds and orthopedic implants, said the U.S. Food and Drug Administration is unable to determine whether these last-generation devices are as safe and effective as their legally marketed predecessor, the Neptune 1.

The recall affects the following products: Neptune 1 Gold Rover; Neptune 1 Gold Rover – International; Neptune 1 Silver Rover; Neptune Bronze; Neptune 2 Rover Ultra (120 V); and Neptune 2 Rover Ultra (230 V).

(Reporting by Debra Sherman; Editing by Gerald E. McCormickand Leslie Adler)


Stryker recalls models of waste management product that did not have requisite 510(k)s

September 25, 2012 3:55 pm by  | 0 Comments

medical device recall 510(k) process PMA

Stryker issued an urgent medical device recall notice Tuesday noting that it was expanding the recall to newer models of a waste management product recalled previously because it was selling those products without the necessary regulatory clearance.

The recall of the Neptune Rover Waste Management System appears to be a worldwide recall. The devices are being recalled because”Stryker has received two reports of serious injury as a result of tissue damage associated with the use of the Neptune 2, including an event in which one customer connected the Neptune 2 System to a passive chest drainage tube postoperatively,” killing the patient.

The company said that the U.S. Food and Drug Administration informed Stryker that the Neptune 1 Silver, Neptune 2 Ultra (120V) and Neptune 2 Ultra (230V) Waste Management systems do not have the requisite 510(k) clearance and customers should stop using these devices. The previous recall was designated a Class I.

As a result of the expanded recall, Stryker is no longer selling these products. Neptune 1 (Gold) Waste Management System is the predicate device for the models being recalled. Those customers who are using the Neptune 1 Gold,Neptune 1 Gold International and the Neptune 1 Bronze will receive follow-up letters containing the warning labels that now need to be applied with these devices.But the announcement noted customers who are currently using the recalled models and do not have an alternative can continue to use them although they need to complete and return a Certificate of Medical Necessity form to Stryker by Oct. 12.

It wasn’t clear from the announcement why these later models of the Neptune 1 Waste Management System were being sold without a 510(k) clearance. A Stryker spokeswoman declined to comment.


Stryker recalls pair of metal hip implants, halts global production

July 6, 2012 by MassDevice staff

Orthopedic devices maker Stryker recalls a pair of metal-on-metal hip implants and halts global production after discovering potential for “fretting and/or corrosion” that could cause pain, swelling and tissue damage.

hip ipmlant x-ray

Orthopedic devices giant Stryker (NYSE:SYK) announced recall of a pair of hip implants over concerns that the devices may be prone to “fretting and/or corrosion at or about the modular-neck junction,” which may lead to pain, swelling and adverse reactions in surrounding tissue.


Massachusetts Stryker Recall Warning:Rejuvenate & ABG II Modular Hip Systems

If you live in Massachusetts and were implanted with a Stryker Rejuvenate hip replacement or a Stryker ABG II hip replacement, you may be at risk for a corrective hip revision surgery. Stryker Orthopaedics warns that fretting and corrosion (wear and tear) can occur within these medical devices. Patients may experience the dangerous side effects of Metallosis (metal poisoning). Hospitalization and painful corrective surgeries are sometimes necessary if a blood test indicates elevated metal levels (cobalt and/or chromium) in a patient’s blood.

Our Stryker hip attorneys are most concerned with the following complications:

  • Implant wear and tear (corrosion or fretting)
  • Metallosis or Metal Poisoning (metal debris causes elevated metal ions in the patients blood)
  • Broken or fractured implants
  • Pseudo-tumors
  • Allergic responses or hypersensitivity
  • Unexplained pain or swelling in leg, hip or groin

Which Stryker Hip Replacements Have Been Recalled?

  • Rejuvenate Modular Hip System recall
  • ABG II modular-neck hip stem recall

Massachusetts patients can verify the model of their hip implant by requesting the operative report from the medical records department at the hospital where the implant surgery took place; or by discussing personally with your surgeon. If you have difficulty finding our whether your implant was part of the Stryker recall, contact us, our Stryker hip lawyers can assist you.

Serious Health Risks Associated with Stryker Hip Recall

Metallosis occurs when metallic debris builds up in the soft tissue around the artificial hip. In the case of the recalled Stryker hip devices, recalled devices are capable of deteriorating and creating metal debris over time. Corrosion or fretting of the device releases microscopic metallic ions of cobalt and chromium into the body, causing an autoimmune response. Metallosis can be further complicated by metal sensitivity or an allergic reaction to metal.

Know Your Legal Rights. Our Law Firm Can Help!

Our Stryker Rejuvenate lawyers are highly experienced in medical device litigation, and we have an impressive record of success to prove it. If you or a loved one has been implanted with a Rejuvenate or ABG II modular hip system in Massachusetts, contact us right away so we can answer your questions, evaluate your claim and explain your legal rights.

Stryker Orthopaedics Recalls Rejuvenate Modular Hip System

In July 2012, Stryker Orthopaedics voluntarily recalled its Rejuvenate Modular Hip System. The recall includes both Stryker’s Rejuvenate Modular and ABG II modular-neck hip stems.


Stryker initiated this voluntary recall due to potential risk associated with modular-neck stems. This risk includes:

  • possible fretting and/or corrosion at the modular-neck junction, which may result in pain and/or swelling.

Other risks associated with Stryker’s hip replacements include:

  • Joint loosening/dislocation
  • Device wear and tear, such as corrosion and fretting
  • Excessive metal debris leading to metal ion generation
  • Inflammation of tissue
  • Hypersensitivity/allergic response
  • Broken devices

Early Failure Rates

The Stryker Orthopaedics Rejuvenate Modular Hip System is associated with early failure rates. Most hip replacements last up to 20 years; however, Stryker Orthopaedics’ device may begin to malfunction at only six months. If you are experiencing any problems with your Stryker Orthopaedics hip implant, including any swelling or other seemingly mild discomfort, you may be eligible for compensation, and you need to contact an experienced attorney right away.

History of Problems with Stryker’s Hip Implants

Stryker Orthopaedic’s voluntary recall follows a May 2012 Health Canada recall and an April 2012 Urgent Safety Alert that Stryker released about serious health risks associated with the product.

The FDA issued warnings to the company from 2005 – 2007 before instituting, in January 2008, a nationwide recall of parts manufactured for use in the socket portion of hip replacements. The FDA recalled the products citing reports that the methods used in Stryker’s manufacturing plants did not conform with good manufacturing practices and that ‘manufacturing residuals’ at levels that exceeded company standards could contaminate the components.

 If you Have Pain…

Stryker Orthopaedics advises recipients of the Rejuvenate Modular Hip or ABG II modular-neck hip stem who have pain or swelling around the replaced hip, to contact their surgeons. Recipients who have no pain, should continue following the post-operative plan outlined by their doctors, the company says.


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