This article is more than 5 years old. Information may no longer be current.

FDA class I recall issued for Zimmer Biomet reverse shoulder device

Add topic to email alerts

Receive an email when new articles are posted on

Please provide your email address to receive an email when new articles are posted on .

Subscribe

Added to email alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

Back to Healio

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

Back to Healio

The FDA recently issued a class I recall for the Zimmer Biomet Comprehensive Reverse Shoulder System Humeral Tray (Model 115340).

According to a medical device recall issued in February by the FDA, the system has a higher fracture rate than stated in the labeling. A class I recall is the FDA’s most serious recall category and indicates a device may cause serious injuries or death.

Zimmer Biomet sent out an Urgent Medical Device Recall Notice and a Certificate of Acknowledgement form on Dec. 20, 2016 to all the customers affected. A total of 3,662 devices were reportedly recalled. Those affected by the recall include health care providers who used the device for reverse shoulder replacement surgeries and patients who underwent total shoulder replacement with the device.

Reference:

www.fda.gov/medicaldevices/safety/listofrecalls/ucm541862.htm