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 Pro Tibial Preparation Tray Recalled by Howmedica Osteonics Corp. Due to Triathlon Pro Tibial Preparation Tray may have been...

Date: November 24, 2021
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 Pro Tibial Preparation Tray, Revision AC- for organization, storage, and transport in preparation for sterilization of re-usable instruments required for implanting the Triathlon Globalization Implant System for individual patients receiving primary total knee arthroplasty (TKA). Catalog# 6541-9-109

Quantity: 7 units

Why Was This Recalled?

Triathlon Pro Tibial Preparation Tray may have been kitted with the Triathlon Cemented #1-3 Keel Punch (P/N: 6541-2-013) instead of the Triathlon Pro #0-3 Cemented Keel Punch (P/N: 6541-2-013Y) instrument can lead to delay in surgery or if used could lead to unintended bone preparation

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.

Related Recalls

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