On February 16, 2017, the FDA issued a Class I recall of Zimmer Biomet’s Reverse Shoulder Humeral Tray, which is the most serious type of recall due to the potential for severe injury. The Comprehensive Reverse Shoulder is a surgically implanted shoulder replacement device that is intended to help restore arm movement in patients with torn rotator cuffs or who have developed arthritis. Shortly after the device’s approval in 2008, patients began to report a number of complications, including device fracture and failure and the need for corrective surgery. Since entering the marketplace, the Comprehensive Reverse Shoulder has been recalled twice, with regulators now directing that use of the device be halted.
If you or a loved one experienced complications or underwent replacement surgery after having a Zimmer Biomet Reverse Shoulder device implanted, please contact us for a confidential evaluation of your potential claim.