Zimmer Biomet Reverse Shoulder Implant News
On December 20, 2016, Zimmer Biomet announced a recall of its Comprehensive Reverse Shoulder Implant based on a higher-than-expected fracture rate. More information on the Comprehensive Reverse Shoulder recall and the affected devices can be found here.
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.
Zimmer Biomet sent an Urgent Medical Device Recall Notice and Certificate of Acknowledgement to medical providers who utilize the Comprehensive Reverse Shoulder device. The notice warned of higher than expected fracture rates in patients using the device.