Zimmer Biomet Recalls Comprehensive Reverse Shoulder due to a High Fracture Rate (FDA)
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Recalled Product:
Product Description: Comprehensive Reverse Shoulder System Humeral Tray Model 115340
Trade Name: Biomet Comprehensive Reverse Shoulder Humeral
Product Code: KWS, PAO
Lot Numbers: All lots with part number 115340; See full list of lot numbers
Distribution Dates: October, 2008 to September, 2015
Manufacturing Dates: August 25, 2008 to September 27, 2011
Devices Recalled: 3662
Device Use
The Comprehensive Reverse Shoulder is a shoulder replacement device that is surgically implanted to help restore arm movement. This device is beneficial for patients with rotator cuff tears who have developed a severe type of shoulder arthritis known as arthropathy and previously failed shoulder joint replacement.
Reason for Recall
Zimmer Biomet is recalling the Comprehensive Reverse Shoulder because these devices are fracturing at a higher rate than is stated in the labeling. Fractures may result in revision surgeries which could cause serious adverse he...
