Warsaw, Indiana—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. The notice asked that the providers:
- Review the safety notice and ensure appropriate staff are aware of the notice
- Identify and quarantine any affected devices in stock
- Complete and return the Certificate of Acknowledgment form within three days by e-mailing the document to corporatequality.postmarket@zimmerbiomet.com
- Retain a copy of the Certificate of the Acknowledgment for records in the event of a compliance audit
The medical providers were advised that a Zimmer Biomet sales representative would remove stock of the affected device from the facilities.
If you or a loved one has received a Zimmer Biomet Comprehenstive Reverse Shoulder implant and you are concerned about your health, immediately contact your physician for an evaluation. If you have been harmed by the device, you should contact an attorney experienced in matters involving defective medical devices.