The FDA has identified Zimmer Biomet Holdings, Inc.’s December 15, 2016’s Comprehensive Reverse Shoulder recall a Class I recall. This class of recall is the most serious type because use of the devices may cause serious injuries or death.
The company recalled the 3,662 devices because these devices are, according to the FDA, “fracturing at a higher rate than is stated in the labeling. Fractures may result in revision surgeries which could cause serious adverse health consequences such as permanent loss of shoulder function, infection, or rarely, death.”
The product description is the Comprehensive Reverse Shoulder System Humeral Tray Model 115340 and goes by the trade name of Biomet Comprehensive Reverse Shoulder Humeral.
All lots with part number 115340 manufactured between August 2008 and September 2011 are being recalled. The lots were distributed between October 2008 and September 2015.
The device 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.
On December 20, 2016, the company sent an Urgent Medical Device Recall Notice and a Certificate of Acknowledgement form to all affected customers. The notice asked customers to:
- Review the safety notice and ensure appropriate staff is aware of the notice.
- Identify and quarantine any affected devices in stock.
- The Zimmer Biomet sales representative will remove the affected device from the facility.
- Complete and return the Certificate of Acknowledgement form within 3 days via email to postmarket@zimmerbiomet.com.
- Retain a copy of the Certificate of Acknowledgement form for records in the event of a compliance audit.
The notice also stated that there are no specific patient monitoring instructions related to this recall that are recommended beyond existing surgical follow up protocol.
Health care professionals and consumers with questions are instructed to contact the 411 Technical Services by phone at 574-371-3071 or by email at corporatequality.postmarket@zimmerbiomet.com with any questions related to this recall. Adverse reactions or quality problems can be reported to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX to 1-800-FDA-0178.
You can read the FDA’s latest update on the recall here.
