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A recall has been issued for a Zimmer Biomet shoulder implant, following a number of reports involving fractures, which could cause severe pain, permanent loss of shoulder function, infections and, in rare cases, death.
The Zimmer Biomet Comprehensive Reverse Shoulder recall was announced by the FDA on February 15. The agency has classified the action as a Class I recall, meaning that the fractured shoulder implants pose a risk of severe injury or death.
The recalled shoulder implants are used to help restore arm movement among individuals with torn rotator cuffs, severe shoulder arthritis known as arthropathy, and patients who had previous shoulder joint replacements that failed. According to the recall notice, the Zimmer Biomet shoulder implants are fracturing at a rate higher than anticipated.
According to the FDA, Zimmer Biomet sent an Urgent Medical Device Recall Notice to its customers on December 20, 2016, asking them to make sure their staff is aware of the problems, to identify and quarantine affected devices, and to return a Certificate of Acknowledgement form. A sales representative from Zimmer Biomet would then come and remove the affected devices.
The FDA determined that this was a class I recall due to those actions and the risk of severe injury or death.
The recall affects 3,662 Biomet Comprehensive Reverse Shoulder Humeral, encompassing all lots with part number 115340. They were manufactured between August 25, 2008 through September 27, 2011; and were distributed between October 2008 and September 2015.
The FDA noted that there are “no specific patient monitoring instructions related to this recall that are recommended beyond existing surgical follow up protocol.
The agency recommends that health care professionals and patients with questions contact the 411 Technical Services at (574) 371-3071 or by email at firstname.lastname@example.org.
Any health care professionals or patients who experience a problem are requested to make a report to MedWatch, the FDA adverse event reporting program.