Biomet, Inc. recalls Comprehensive Humeral Tray Taper Extraction Pliers - Replacement Tips, Model Number 110028522 - Product Usage: Intended

Recalled April 29, 2020 · FDA recall Z-1750-2020 · Biomet

Hazard

There were unknown bioburden levels prior to sterilization, which may affect sterility of the product. · FDA Class II

Units

125

Sold at

Worldwide distribution - US Nationwide distribution including the states of AL, CO, KS, MA, MD, MI, MO, NH, NJ, and PA. The countries of Australia, Canada, India, and Netherlands.

Description

There were unknown bioburden levels prior to sterilization, which may affect sterility of the product.

Product

Comprehensive Humeral Tray Taper Extraction Pliers - Replacement Tips, Model Number 110028522 - Product Usage: Intended to be used in surgery to relieve pain and to replace the glenoid and humeral side of the shoulder joint in order to restore mobility in a grossly rotator cuff deficient joint with severe arthropathy or a previous joint replacement with a grossly rotator cuff deficient joint.

Manufacturer(s)

Biomet, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →