Biomet, Inc. recalls Comprehensive Shoulder System Mini Humeral Stem 9mm,, Model No. 113629 - Product Usage: The intended use of the compreh…

Recall date

February 17, 2020

Source

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

Recall number

Z-1543-2020

FDA classification

Class II

Brand / firm

Biomet, Inc.

Sold / distributed

International distribution in the countries of Canada, Japan, Netherlands, South Korea.

Why it was recalled

A 15mm Shoulder Mini Humeral Stem was misidentified as a 9mm Shoulder Mini Humeral Stem.

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 Shoulder System Mini Humeral Stem 9mm,, Model No. 113629 - Product Usage: The intended use of the comprehensive humeral stem mini is to act as the humeral component of the comprehensive total shoulder system.