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

Recalled April 1, 2020 · FDA recall Z-1543-2020 · Biomet

Hazard

A 15mm Shoulder Mini Humeral Stem was misidentified as a 9mm Shoulder Mini Humeral Stem. · FDA Class II

Units

14 units

Sold at

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

Description

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

Product

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.

Manufacturer(s)

Biomet, Inc.

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