Class 1 Recall: Zimmer Biomet Recalls Comprehensive Reverse Shoulder due to a High Fracture Rate
Zimmer Biomet is recalling the Comprehensive Reverse Shoulder because these devices are fracturing at a higher rate than is stated in the labeling.
Thu Feb 16 2017
Class 1 Recall: Zimmer Biomet Recalls Comprehensive Reverse Shoulder due to a High Fracture Rate
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 health consequences such as permanent loss of shoulder function, infection, or rarely, death.
Who May be Affected
- Health care providers using this device during reverse shoulder replacement surgeries
- Patients receiving total shoulder replacements using this device
What to Do
On December 20, 2016 Zimmer Biomet 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 corporatequality.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.
Contact Information
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.
Date Recall Initiated:
December 15, 2016