After receiving a significant number of reports from patients, regarding an unusually high fracture rate of the Zimmer Biomet Comprehensive Reverse Shoulder implant, a recall of the device was announced on February 15th. The FDA announced the recall, classifying it as a Class I recall—the most serious type of recall.
Just How Serious Is an FDA Class I Recall?
A class I recall is reserved for devices which pose a risk of severe injury or death to consumers. In the case of the Zimmer Biomet Comprehensive Reverse Shoulder implant, fractures of the device can result in infection, loss of shoulder function, severe pain, and, in rare cases, death. The recall notice for the device states the shoulder implants are fracturing at a higher rate than expected.
When the FDA receives information that a product may be defective or has adverse health implications for patients, a recall may be issued. When a Class I recall is issued by the FDA, you can assume there is significant and immediate danger of serious injury or death. Class I recalls are relatively rare, and are accompanied by a plan for the manufacturer to ensure recall compliance. The FDA will also want to ensure the recalled device is trackable so that all the affected devices are removed from the market.
Recall Details for the Zimmer Biomet Comprehensive Reverse Shoulder Implants
Patients who have suffered such medical issues as a torn rotator cuff, severe shoulder arthritis, or who have limited arm movements, are among those who may have received a Zimmer Biomet Comprehensive Reverse Shoulder implant. Zimmer Biomet sent an Urgent Medical Device Recall Notice on December 20, 2016 to customers of the implant, asking that they “identify and quarantine” the affected devices.
To ensure customers are fully aware of the problems associated with the implants, Zimmer asked them to return a Certificate of Acknowledgement form within three days. After Zimmer Biomet receives the Certificates, a sales representative will be sent to the customer’s location to remove all affected devices. The recall affects all Zimmer Biomet Comprehensive Reverse Shoulder implants with part number 115340. There are 3,662 of these devices manufactured between August 2008 and September 2011, and distributed between October 2008 and September 2015.
No Current Patient Monitoring Instructions from the FDA
Those affected by the recall are health care providers who use the Zimmer Biomet Comprehensive Reverse Shoulder devices, as well as the patients who have received one of these shoulder replacement devices. At the time of the recall, the FDA stated there were no current patient monitoring instructions related to the recall beyond the normal surgical follow-up protocols. Despite this, if you have experienced any problems with your Zimmer Biomet device, make an appointment with your physician at the earliest possible time.
Getting Help from an Experienced Alabama Product Liability Attorney
This latest recall joins what seems to be a flurry of recalls and problems with artificial hips, knees and shoulders over the past few years. If you have suffered injury from a Zimmer Biomet Comprehensive Reverse Shoulder device—or other recalled or dangerous devices—it could be extremely beneficial for you to contact a Martinson & Beason product liability attorney. Our attorneys have helped people just like you for many, many years. We have extensive experience with dangerous drugs and medical devices, as well as a thorough understanding of the medical treatments associated with injuries from these drugs and devices. Call Martinson & Beason today for a compassionate, knowledgeable assessment of your injuries.