Why Zimmer Biomet is Recalling Comprehensive Reverse Shoulder
Shoulder replacements are typically surgically implanted on patients with limited shoulder and arm functions, such as those with arthritis caused by large rotator cuff tears. One such replacement is the Comprehensive Reverse Shoulder device by Zimmer Biomet. It is used to relieve pain and significant disability caused by a deficiency in the rotator cuff. However, there are some patients who are not allowed to acquire the device, such as those with infections, sepsis, and osteomyelitis.
Zimmer Biomet is starting to recall the device because its fracture rate is higher than what has been anticipated. In fact, the Food and Drug Administration has designated the recall as a Class I, which is the highest class of recall. Class I Recall is issued for products that may sustain injury and death. In the case of Zimmer Biomet Comprehensive Reverse Shoulder, these may be sustained because of revision surgery to remove the device and replace it with another that has the adequate fracture rate. The injuries that can be sustained from Zimmer shoulder recall may even result into the permanent loss of function in the shoulder area.
According to the recall article from the website of the FDA, affected customers have been asked to do the following:
- 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@example.com
- Retain a copy of the Certificate of Acknowledgement form for records in the event of a compliance audit
Aside from the threats of injury, infection, loss of shoulder function, and death, the Zimmer shoulder recall may have more consequences to the patient, such as the financial damages associated with corrective surgery, hospital confinement, loss time at work, and loss of earning capability because of health complications.
Designers and manufacturers are legally obligated to ensure the safety of their products, and any form of negligence that has resulted into damages on the side of the customer can be subject to a lawsuit. For this reason, many affected patients are seeking compensation.