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

Recall date

March 13, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1750-2020

FDA classification

Class II

Brand / firm

Biomet, Inc.

Sold / distributed

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.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.