Class II — Potential Health Hazard

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

Attune Revision Limb Preservation System (LPS) Tibial Insert SM 12MM Recalled by DePuy Orthopaedics, Inc. Due to The subject product lots are being recalled because...

Date: February 15, 2023
Company: DePuy Orthopaedics, Inc.
Status: Ongoing
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 DePuy Orthopaedics, Inc. directly.

Affected Products

Attune Revision Limb Preservation System (LPS) Tibial Insert SM 12MM, Part Number 151760312

Quantity: 7 units

Why Was This Recalled?

The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant material properties.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About DePuy Orthopaedics, Inc.

DePuy Orthopaedics, Inc. has 154 total recalls tracked by RecallDetector.

Related Recalls

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