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 Reverse Shoulder Instrument Case Outer (Outer Case Vault Only) Recalled by Zimmer Biomet, Inc. Due to Lack of an adequate sterilization validation.

Date: June 10, 2019
Company: Zimmer 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 Zimmer Biomet, Inc. directly.

Affected Products

Comprehensive Reverse Shoulder Instrument Case Outer (Outer Case Vault Only), Item Number 595509

Quantity: 92

Why Was This Recalled?

Lack of an adequate sterilization validation.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Zimmer Biomet, Inc.

Zimmer Biomet, Inc. has 875 total recalls tracked by RecallDetector.

Related Recalls

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