FDA Recalls Zimmer Biomet Shoulder: High Fracture Rate
Published on April 13, 2017
Class 1 Recall
The FDA has announced a Class 1 Recall of the Zimmer Biomet Comprehensive Reverse Shoulder Humeral Tray (Model 115339) following reports that the devices are fracturing at a higher rate than stated in the labeling. In December Zimmer Biomet had sent an Urgent Medical Device Recall Notice to doctors, hospitals and other medical providers recalling the reverse shoulder implants, asking that all devices in stock be identified and quarantined for removal. The FDA has now classified this recall as a Class 1 Recall, meaning that the use of these shoulder replacements may cause serious injury or death.
What is a Biomet Comprehensive Reverse Shoulder Implant?
The Biomet Comprehensive Reverse Shoulder System Humeral Tray Model 115339 is a shoulder replacement device that is surgically implanted. It is used in patients who have suffered rotator cuff tears who have also developed a severe form of arthritis called arthropathy and also already had a failed shoulder replacement.
Zimmer’s recall of the Biomet Comprehensive Reverse Shoulder implant applies to 3,662 devices manufactured between August 25, 2008 and September 27, 2011, which were distributed between October 2008 and September 2015.
The devices in question were manufactured by Biomet. Biomet was acquired by Zimmer in 2015 for $14 billion dollars.
What’s Wrong With the Biomet Comprehensive Reverse Shoulder Implant?
The devices fracture more than expected. Fractures of a defective shoulder implant may cause permanent loss of shoulder function, infection, or even death. Patients may be required to undergo another revision surgery to remove, or remove and replace, the implant, with all the risks of surgery.
What Can You Do?
If you have had shoulder replacement using the Biomet Comprehensive Reverse Shoulder implant and suffered a fracture, you may have a claim for damages. Contact the defective medical device attorneys at Thornton Law Firm for a free, thorough evaluation of your legal rights at 1-888-341-1405. Or tell us your story using our online contact form. Like all legal claims, defective shoulder implant claims must be filed within short time limits. Get legal advice as soon as possible to protect your rights.