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Zimmer Biomet Recalls Comprehensive Reverse Shoulder, Cites High Fracture Rate, says FDA

February 17, 2017
Home Firm News Zimmer Biomet Recalls Comprehensive Reverse Shoulder, Cites High Fracture Rate, says FDA

We are no longer accepting new cases.

Weitz & Luxenberg is currently accepting cases from people harmed by a faulty shoulder replacement device made by Zimmer Biomet.

The medical device manufacturer issued a recall of its Comprehensive Reverse Shoulder because specific devices were fracturing at a higher rate than specified in the labeling, according to the U.S. Food & Drug Administration’s (FDA) announcement of the recall.

The FDA has designated this recall as Class I, its most serious type of recall classification. A Class I recall means use of these devices may cause serious injuries or death, the FDA noted.

Zimmer Biomet’s Comprehensive Reverse Shoulder

The Comprehensive Reverse Shoulder is a shoulder replacement device that is surgically implanted. The device is intended to be used in primary, fracture, or revision shoulder replacement.

The shoulder replacement is intended for patients with rotator cuff tears who have developed severe arthropathy, a type of shoulder arthritis, or whose past shoulder joint replacement failed in the presence of severe rotator cuff deficiency.

Before Zimmer acquired Biomet for $14 billion in 2015, Biomet manufactured the devices subject to the recall starting in August 2008.  Biomet started distributing the devices in October of the same year.

Zimmer Biomet Issues Urgent Recall Notice

On December 20, 2016, Zimmer Biomet sent an Urgent Medical Device Recall Notice and a Certificate of Acknowledgement form to all affected customers, asking them to “identify and quarantine any affected devices in stock.”

The company’s recall applies to 3,662 devices that were manufactured between August 25, 2008, and September 27, 2011, and distributed between October 2008 and September 2015.

The recall notice did not recommend specific patient monitoring instructions, but instead stated that surgeons should proceed with existing surgical follow-up protocols.

Device Use May Result in Revision Surgery, Which Can Cause Serious Adverse Health Consequences

Zimmer Biomet’s reason for recalling its Comprehensive Reverse Shoulder is that the devices are fracturing at a higher rate than is stated in the labeling. Device fractures may require patients to undergo revision surgery, which is a second surgery to remove or replace an implant.

As the FDA’s notice of the recall states, revision surgery “could cause serious adverse health consequences such as permanent loss of shoulder function, infection, or rarely, death.”

Previous Comprehensive Reverse Shoulder Recalls

The December 2016 recall is not the first involving the Comprehensive Reverse Shoulder. Biomet previously recalled some of its Comprehensive Reverse Shoulder products in 2010 after receiving complaints regarding fracturing of the Comprehensive Reverse Shoulder Humeral Tray with Locking Ring.

At that time, the company sent an Urgent Medical Device Recall Notice to their distributors and customers stating that the recalled devices should be immediately located, discontinued from use, and shipped back to Biomet.

In a separate Urgent Medical Device Recall Notice to implanting surgeons, the company informed surgeons of the recall and instructed them to continue to monitor their patients for fracture of the devices.

The recall was terminated in July 2011, according to the FDA website.

In January 2015, Biomet initiated a recall of its Comprehensive Reverse Shoulder Glenosphere Mini Baseplate 25mm with Taper Adaptor. According to the FDA website, the taper adaptor was missing from the packaging, which could have resulted in a delay in surgery greater than 30 minutes. The recall was terminated about nine months later.

Weitz & Luxenberg Nationally Recognized in Medical Device Cases

Weitz & Luxenberg is a driving force in the field of defective medical device litigations. The nationally recognized law firm wants to hear from people who underwent revision surgery after their Zimmer Biomet Comprehensive Reverse Shoulder implant fractured.

An experienced attorney can help you determine if you have grounds to bring a lawsuit to obtain compensation for any damages suffered as a result of a Zimmer Biomet Comprehensive Reverse Shoulder implant.

We would feel privileged to assist you. For a free consultation and more information about your legal options, please contact us today.”

Weitz & Luxenberg has a more than 30-year track record of securing significant victories for people injured by faulty implants. With nearly 500 attorneys, paralegals, and support staff, the firm has provided exceptional and compassionate legal support to more than 50,000 clients across the U.S.

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