class 1 recall issued for the zimmer biomet comprehensive reverse shoulder
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 [email protected]
- 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 [email protected] with any questions related to this recall.
Date Recall Initiated:
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program (https://www.accessdata. fda.gov/scripts/medwatch/index.cfm) either online, by regular mail or by FAX to 1-800-FDA-0178.
Class 1 Recall issued for the Zimmer Biomet Comprehensive Reverse Shoulder recalled by the FDA due to Serious Device Fractures
Meyers & Flowers has learned that the U.S. Food & Drug Administration (FDA) has issued a Class 1 Recall for the Zimmer Biomet Comprehensive Reverse Shoulder. It has been found that the shoulder replacement devices are fracturing at a higher rate than stated in Zimmer Biomet’s labeling.
Fractures due to the Zimmer Biomet medical device may result in revision surgeries that could lead to serious injury, crippling pain, permanent loss of shoulder function, infection and rarely, death.
Approximately 53,000 shoulder replacement procedures are done annually according to the American Academy of Orthopaedic Surgeons. However, it has been found that this procedure is not beneficial for patients with large rotator cuff tears who developed cuff tear arthropathy, a severe type of shoulder arthritis. Because conventional replacement surgery may result in pain and limited shoulder motion, these patients may benefit from a reverse total shoulder replacement procedure. The recalled Zimmer Biomet Comprehensive Reverse Shoulder is a shoulder replacement device designed to restore arm movement for patients suffering from rotator cuff tears that have developed arthropathy and previously failed shoulder joint replacement.
Class 1 recalls are the agency’s most serious type of recall and are only issued when there is a reasonable probability of the medical device causing serious injury or death. The recalled product information on the Zimmer Biomet Comprehensive Reverse Shoulder includes:
- 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; Click here to see a full list of lot numbers
- Distribution Dates: October, 2008 to September, 2015
- Manufacturing Dates: August 25, 2008 to September 27, 2011
- Devices Recalled: 3662
Meyers & Flowers has decades of experience litigating cases against Zimmer Biomet and similar device manufacturers for defective and harmful medical devices. If you or family member injured by the Comprehensive Reverse Shoulder device, contact our office so we may explore with you, your legal options.
Meyers & Flowers is internationally known for our expertise in defective medical device litigation; we can help. Contact us online, (630) 232-6333 or request a free case evaluation online.