Access Now: AORN COVID-19 Clinical Support

Home E-Weekly February 21, 2017

Zimmer Biomet Recalls More than 3,600 Shoulder Implants Due to a High Fracture Rate

Published: February 21, 2017

LAST RESORT The Comprehensive Reverse Shoulder is used when shoulder joint replacements have failed.

Zimmer Biomet is recalling more than 3,600 Comprehensive Reverse Shoulder implants that it says have been fracturing at a dangerously high rate, endangering patients.

Classified as Class I by the FDA, because the device in question can cause serious injuries or death, the recall covers implants that were distributed between October 2008 and September 2015.

The implant is designed for patients whose shoulder joint replacements have failed. When it fractures, it requires revision surgeries that could cause permanent loss of shoulder function, infection, or, in rare circumstances, death.

Zimmer Biomet sent recall notices to all affected customers in December, asking them to quarantine any devices they have in stock, return a Certificate of Acknowledgement and wait for a company rep to remove any such devices. No special patient monitoring instructions related to the recall are recommended.

All lots with part number 115340 are subject to the recall. The full list of lot numbers is included in the FDA's notice.

Call the 411 Technical Services at (574) 371-3071 or email with any questions related to the recall.

Jim Burger

New to Outpatient Surgery Magazine?
Sign-up to continue reading this article.
Register Now
Have an account? Please log in:
Email Address:
  Remember my login on this computer

advertiser banner

Other Articles That May Interest You