Class II — Potential Health Hazard

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

Vanguard Complete Knee System Recalled by Zimmer Biomet, Inc. Due to Two lots of tibial bearings were commingled. There...

Date: May 24, 2018
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

Vanguard Complete Knee System; E1 Vanguard PS Tibial Bearing; Model Numbers EP-183664, EP-183642 Product Usage: The product is intended for use in knee joint replacement arthroplasties.

Quantity: 48

Why Was This Recalled?

Two lots of tibial bearings were commingled. There is a possibility that a 14mm tibial bearing is packaged in a box labeled as 12 mm tibial bearing and vice versa. This may lead to extension of surgery to find another implant.

Where Was This Sold?

This product was distributed to 18 states: CA, CT, GA, IN, IA, LA, MD, MA, MN, MS, NJ, OH, PA, TN, TX, UT, VA, WI

Affected (18 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