Class II — Potential Health Hazard

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

Orthopedic Salvage System (OSS) 9cm prosthesis Recalled by Zimmer Biomet, Inc. Due to Mislabeling

Date: December 16, 2016
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

Orthopedic Salvage System (OSS) 9cm prosthesis, knee, femorotibial, constrained, cemented, metal/polymer Knee System Tibial Bodies

Quantity: 16

Why Was This Recalled?

labeling for specific lots of the Standard OSS Modular Proximal Tibia incorrectly identifies the components as AVL Modular Proximal Tibia. The mislabeling could have the potential risks: A delay in surgery less than 30 minutes. Patient undergoes a revision with increased risk of infection.

Where Was This Sold?

This product was distributed to 8 states: CA, LA, MD, MA, NJ, TX, WA, WI

Affected (8 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