Class II — Potential Health Hazard

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

Tibial Opening Wedge Osteotomy Plate Recalled by Arthrex, Inc. Due to It was discovered that five AR-13200ST-15.0 parts were...

Date: March 11, 2021
Company: Arthrex, 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 Arthrex, Inc. directly.

Affected Products

Tibial Opening Wedge Osteotomy Plate, Titanium, 15.0 mm - Product Usage: use in treatment of non-union, mal-union, and fractures of the proximal tibia and distal femur.

Quantity: 32 units

Why Was This Recalled?

It was discovered that five AR-13200ST-15.0 parts were processed as AR-13200T-15.0 parts.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Arthrex, Inc.

Arthrex, Inc. has 28 total recalls tracked by RecallDetector.

Related Recalls

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