Silver Spring, Maryland—The FDA has provided additional information to patients and medical providers regarding the recall of the Comprehensive Reverse Shoulder Implant initiated by Zimmer Biomet on December 20, 2016. The recall has been designated a “Class 1” recall, which reflects the highest classification available to the FDA. Class 1 recalls are reserved for those products where there is a reasonable probability that the use of the device will cause serious adverse health consequences or death.
Recalled Product
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
Distribution Dates
October 2008 to September 2015
Manufacturing Dates
August 25, 2008 to September 27, 2011
Number of Devices Recalled
3,662
If you believe you may have one of the affected devices, you should promptly consult your physician for an evaluation.
You may also be entitled to compensation and should contact an attorney experienced in cases involving defective medical devices to learn about your legal rights.