News & Analysis as of

Medical Devices Product Recalls

Searcy Denney Scarola Barnhart & Shipley

Defective Medical Devices and Their Impact on Patient Safety

Defective medical devices present serious risks for patients. Just how big—and how severe—is the problem? Consider this from the U.S. Food and Drug Administration (FDA): “Each year, the FDA receives over two million medical...more

Searcy Denney Scarola Barnhart & Shipley

Recalled Medical Devices: How to Check If You Have One

Numerous medical devices sold in the United States are subject to active recalls. If you have a medical device that is subject to an active recall, it will be important to make sure you know what this means for your health...more

Gardner Law

Change Control Pitfalls: Legal & Regulatory Risks in FDA-Regulated Industries

Gardner Law on

Obtaining FDA clearance or approval is just the beginning of a company’s regulatory journey. As FDA-regulated products evolve, changes to software, labeling, manufacturing processes, and design are a natural part of the...more

Searcy Denney Scarola Barnhart & Shipley

FDA Recalls: How to Stay Informed About Unsafe Products

Unsafe product recalls are alarmingly common. While all companies have a legal obligation to ensure that their products are safe for use or consumption, companies fail to meet this obligation far too often. In many cases,...more

Miles Mediation & Arbitration

Mass Tort Cases: Challenges for Plaintiff’s and Defense Counsel

Mass tort cases present unique challenges for both plaintiff’s and defense counsel. Unlike a class-action case, where a representative plaintiff stands in for the other members of the class, each plaintiff in a mass tort case...more

Akin Gump Strauss Hauer & Feld LLP

FDA Announces Plan to Speed Up Public Notification About Potentially High-Risk Device Recalls

On November 21, 2024, FDA’s Center for Devices and Radiological Health (CDRH) announced a pilot program aimed at improving public notice about potentially high‑risk medical device recalls. The pilot seeks to reduce the time...more

Bennett Jones LLP

Amended Recall Requirements for Medical Devices and Pharmaceutical Products in Canada

Bennett Jones LLP on

Health Canada is making changes (via legislative amendments) to the manner in which medical devices and pharmaceutical products are recalled under the Medical Device Regulations, SOR/98-282 (MDR) and the Food and Drug...more

Spilman Thomas & Battle, PLLC

The Health Record - Healthcare Law Insights, Issue 5, September 2024

Welcome to our fourth issue of The Health Record - our healthcare law insights e-newsletter. In this edition, we take a look at the Biden administration's proposed insurance rule regarding mental health and substance use...more

Spilman Thomas & Battle, PLLC

Decoded - Technology Law Insights, V 5, Issue 7, August 2024

Welcome to our seventh 2024 issue of Decoded - our technology law insights e-newsletter. We have a few events we want to pass along to those interested in technology, but also other areas of law and business. ...more

Stikeman Elliott LLP

Regulatory Amendments Impacting Drug and Medical Device Recalls Coming Into Force

Stikeman Elliott LLP on

On December 17, 2024, recent amendments to the Food and Drug Regulations (FDR) and the Medical Devices Regulations (MDR) relating to the recall of drugs and medical devices will come into force....more

Searcy Denney Scarola Barnhart & Shipley

The Role of the FDA in the Exactech Recall: A Critical Analysis

Exactech has issued multiple recalls for its implantable joint replacement devices over the past few years. While Exactech has largely issued these recalls voluntarily, it has done so at the request—and with the oversight—of...more

Searcy Denney Scarola Barnhart & Shipley

Lessons Learned from the Exactech Recall: How We Can Improve Medical Device Safety in the Future

In response to scrutiny from the U.S. Food and Drug Administration (FDA), Exactech has recalled hundreds of thousands of defective medical implant devices sold between 2004 and 2021. Despite these recalls—which began in...more

ArentFox Schiff

MoCRA Compliance: Key Legal Issues for Fashion Houses with Cosmetics

ArentFox Schiff on

As we have reported at length, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) imposed extensive new requirements related to cosmetic products marketed in the United States. As compliance deadlines for these new...more

Searcy Denney Scarola Barnhart & Shipley

Alternatives to the Exactech: Exploring Other Surgical Tools and Techniques

Over the past couple of decades, hundreds of thousands of patients in the United States have received defective medical implants manufactured by Exactech. While the U.S. Food and Drug Administration (FDA) has identified...more

Searcy Denney Scarola Barnhart & Shipley

A Timeline of the Exactech Recall: How it Unfolded

Exactech has recalled hundreds of thousands of implantable ankle, knee, hip and shoulder replacement devices over the past few years. If you or a loved one received an Exactech implant in 2004 or later, it will be important...more

Searcy Denney Scarola Barnhart & Shipley

The Legal Implications of the Exactech Recall for Patients and Hospitals

Exactech is a manufacturer of medical implants, including ankle, knee, hip and shoulder replacement devices. Unfortunately, due to poor manufacturing practices and quality control issues, Exactech has been forced to recall...more

Searcy Denney Scarola Barnhart & Shipley

What to Do If You've Been Affected by the Exactech Recall

If you have had problems with an Exactech ankle, knee, hip or shoulder implant, you are not alone. At the request of the U.S. Food and Drug Administration (FDA), Exactech has recalled hundreds of thousands of defective ankle,...more

Searcy Denney Scarola Barnhart & Shipley

Exactech Shoulder Replacement Systems: What You Need to Know

Exactech is a medical device company that has faced numerous lawsuits in recent years. These lawsuits have focused on various issues with the company’s implantable medical devices, including issues that the company has...more

Searcy Denney Scarola Barnhart & Shipley

The Exactech Recall: A Quick Synopsis and Update on What You Need to Know

Exactech is a medical device company that manufactures implantable joint replacements. It is also a company that has faced numerous lawsuits related to its products in recent years. In many cases, Exactech has acknowledged...more

Searcy Denney Scarola Barnhart & Shipley

The Impact of the Exactech Recall on Patient Safety

Exactech has recalled hundreds of thousands of its implantable medical devices. This includes ankle, hip, knee and shoulder implants that the company shipped to doctors’ offices and hospitals across the country. These recalls...more

American Conference Institute (ACI)

[Event] 41st FDA Boot Camp - September 20th - 21st, Boston, MA

ACI’s FDA Boot Camp is back in Boston! This essential training course – now in its 41st iteration – continues to provide the working knowledge of core essentials of FDA law and regulation, including the new amendments under...more

Epstein Becker & Green

Unpacking Averages: Analyzing the Relationship Between MDRs and Recalls

Recently Colleen and Brad had a debate about whether Medical Device Reports (“MDRs”) tend to trail recalls, or whether MDRs tend to lead to recalls. Both Colleen and Brad have decades of experience in FDA regulation, but we...more

Patrick Malone & Associates P.C. | DC Injury...

Botched. Belabored. Enough already. Fix the FDA and Philips recall

While critics long have ripped the Food and Drug Administration for its weak oversight of medical devices and its too cozy relationships with their makers, the federal agency and a Dutch global conglomerate have given...more

Goodwin

Genentech Voluntarily Recalls SUSVIMO (ranibizumab)

Goodwin on

​​​​​​​This month, Genentech announced a voluntary recall of the ranibizumab injection (SUSVIMO) ocular implant and associated insertion tool. SUSVIMO, which provides continuous administration of the anti-VEGF (vascular...more

Robins Kaplan LLP

Update on Exactech Knee, Hip, and Ankle Implant Recall Lawsuit

Robins Kaplan LLP on

Robins Kaplan LLP is examining the recent recall of orthopedic devices that were manufactured by Exactech for hip, knee, and ankle implants. Since 2021, Exactech has recalled approximately 185,000 devices with the latest...more

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