February 15, 2017, the FDA announced a Class I recall of the Zimmer Biomet Comprehensive Reverse Shoulder implant because these devices are fracturing at a higher rate than stated in the labeling. If this occurs, patients may need a revision surgery to remove or replace the device.
The FDA has identified this as a Class I recall, which is the most serious type of recall. Use of these devices may cause serious injuries or death.
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.
Zimmer Biomet, the manufacturer of the device, is recalling it because the devices are fracturing at a higher rate than is stated in the labeling.
Fractures may result in serious pain and force you to have revision surgery to remove or replace the device. As with all revision surgeries, there is an increased risk of suffering serious adverse health consequences such as permanent loss of shoulder function, infection or possibly death.
Zimmer Biomet initiated the recall of this implant on December 20, 2016 when it sent an Urgent Medical Device Recall Notice to affected customers.
The recall notice alerted doctors and healthcare facilities that the implant should not be used and that Zimmer Biomet would collect any existing devices. The notice instructed doctors to continue monitoring patients implanted with the recalled device but provided no additional patient monitoring instructions.
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