Class II — Potential Health Hazard

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

TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM-Intended for knee Recalled by Howmedica Osteonics Corp. Due to Mislabeling

Date: April 13, 2023
Company: Howmedica Osteonics Corp.
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 Howmedica Osteonics Corp. directly.

Affected Products

TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM-Intended for knee replacement Catalog Number: 5531-G-312-E

Quantity: 24 units in total

Why Was This Recalled?

Mislabeled:Labeled Catalog Number: 5531-G-312-E, TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM, may contain Catalog Number: 5532-G-413-E, TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM, and vice versa

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Howmedica Osteonics Corp.

Howmedica Osteonics Corp. has 229 total recalls tracked by RecallDetector.

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