Defective Shoulder Implant Lawyers
On December 20, 2016, Zimmer Biomet sent an Urgent Medical Device Recall Notice and a Certificate of Acknowledgement form to all affected customers to “identify and quarantine any affected devices in stock.” The recall applies to 3,662 devices that were distributed between October 2008 and September 2015.
Zimmer Biomet Urgent Recall Notice
Zimmer Biomet recalled the Comprehensive Reverse Shoulder because the devices are fracturing at a higher rate than stated in its labeling. Fractures may subject patients to revision surgeries. According to the FDA notice, these revision surgeries, “can have serious adverse health consequences such as permanent loss of shoulder function, infection, or rarely, death.”
The recall notice did not provide specific monitoring instructions for fractures, but instead advised surgeons to continue with typical surgical follow-up protocols.
The Zimmer Biomet Comprehensive Shoulder was introduced to the United States in 2008. It is a surgically implanted shoulder replacement device intended to be used in primary, fracture or revision shoulder replacement. Specifically, it is intended to benefit patients with rotator cuff tears that have progressed to severe shoulder arthritis and those with previously failed shoulder joint replacements.
The U.S. Food & Drug Administration (FDA) has recently announced Zimmer Biomet issued a recall of its Comprehensive Reverse Shoulder because specific devices were fracturing at a higher rate than specified in the labeling. The FDA has designated this recall as Class I, meaning that the use of these devices may cause serious injuries or death. A Class I recall is the most severe classification.
Our New York defective medical device lawyers are now accepting cases from people harmed by the faulty Zimmer Biomet Comprehensive Shoulder.
Previous Reverse Shoulder Recalls
Prior to the December 2016 recall, there were previous recalls associated with some of Biomet’s Comprehensive Reverse Shoulder products.
In 2010, Biomet’s Comprehensive Reverse Shoulder Humeral Tray with Locking Ring was recalled after receiving complaints of fracturing. Accordingly, Biomet instructed their distributors and customers to immediately locate and discontinue use of the affected products. Further, in a separate Urgent Medical Device Recall Notice to implanting surgeons, Biomet informed surgeons to monitor their patients for fractures of the devices. The recall was terminated in July 2011.
Our New York defective medical device attorneys are able to handle a wide range of product liability claims, including those involving the Zimmer Biomet Comprehensive Shoulder implant. Call (888) 260-0473 for a free case evaluation.