NEW YORK, Feb. 21, 2017 /PRNewswire/ -- A Class I recall has been announced for the Zimmer Biomet Comprehensive Reverse Shoulder Humeral Tray (Model 115340), following a determination that these devices are fracturing at a higher rate than is stated in the labeling. Class I is the U.S. Food & Drug Administration's (FDA) most serious recall category, and indicates that the products included in the Zimmer Biomet shoulder replacement recall may cause serious injuries or death.
"Individuals who experience a fracture of their Zimmer Biomet shoulder replacement may require revision surgery, which can result in permanent loss of shoulder function, infection and even death," says Sandy A. Liebhard, a partner at Bernstein Liebhard LLP, a nationwide law firm representing plaintiffs who have been harmed by recalled medical devices. The Firm is now offering free legal reviews to individuals who suffered injuries and complications related to a Zimmer Biomet shoulder replacement fracture.
Zimmer Biomet Comprehensive Reverse Shoulder: What's the Problem?
On December 20, 2016, Zimmer Biomet issued an Urgent Medical Device Recall Notice and a Certificate of Acknowledgement regarding certain Comprehensive Reverse Shoulder Humeral Trays that had been associated with a higher-than-anticipated rate of fracture. The notice affected 3,662 Comprehensive Reverse Shoulder Humeral Trays:
- Manufactured from August 25, 2008 to September 27, 2011
- Distributed from October 2008 to September 2015
- Product Codes: KWS, PAO
- All lots with part number 115340
On February 16, 2017, the FDA announced that it had designated Zimmer Biomet's notice a Class I recall According to the agency, there are "no specific patient monitoring instructions related to this recall that are recommended beyond existing surgical follow up protocol."
The Zimmer Biomet Comprehensive Reverse Shoulder is indicated to restore arm movement in patients undergoing reverse shoulder replacement. The device is beneficial in individuals with rotator cuff tears who have developed a severe type of shoulder arthritis known as arthropathy and previously failed shoulder joint replacement. The Comprehensive Reverse Shoulder was brought to market via the FDA's 510(K) program, which allows a medical device manufacturer to forgo human clinical trials if they are able to demonstrate that a product is "substantially equivalent" to another device that was previously approved by the agency.
Recipients of the Comprehensive Reverse Shoulder who experienced a fracture related to this recall may be entitled to compensation for their pain and suffering. To learn more about filing a Zimmer Biomet shoulder replacement lawsuit, lease visit Bernstein Liebhard LLP's website, or call 800-511-5092.
About Bernstein Liebhard LLP
Bernstein Liebhard LLP is a New York-based law firm exclusively representing injured persons in complex individual and class action lawsuits nationwide since 1993. As a national law firm, Bernstein Liebhard LLP possesses all of the legal and financial resources required to successfully challenge billion dollar pharmaceutical and medical device companies. As a result, our attorneys and legal staff have been able to recover more than $3.5 billion on behalf of our clients. Bernstein Liebhard LLP is honored to once again be named to The National Law Journal's "Plaintiffs' Hot List," recognizing the top plaintiffs firms in the country. This year's nomination marks the thirteenth year the firm has been named to this prestigious annual list.
Bernstein Liebhard LLP
10 East 40th Street
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ATTORNEY ADVERTISING. © 2017 Bernstein Liebhard LLP. The law firm responsible for this advertisement is Bernstein Liebhard LLP, 10 East 40th Street, New York, New York 10016, 800-511-5092. Prior results do not guarantee or predict a similar outcome with respect to any future matter.
Sandy A. Liebhard, Esq.
Bernstein Liebhard LLP
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SOURCE Bernstein Liebhard LLP