Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Comprehensive Shoulder System Mini Humeral Stem 9mm Recalled by Biomet, Inc. Due to A 15mm Shoulder Mini Humeral Stem was misidentified...

Date: February 17, 2020
Company: Biomet, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Biomet, Inc. directly.

Affected Products

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.

Quantity: 14 units

Why Was This Recalled?

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

Where Was This Sold?

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

About Biomet, Inc.

Biomet, Inc. has 250 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report