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 FEMORAL DISTAL AUGMENT 10MM - SIZE 2 RIGHT Catalog Recalled by Howmedica Osteonics Corp. Due to Due to device overhang issue that protrudes beyond...

Date: August 19, 2019
Company: Howmedica Osteonics Corp.
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 Howmedica Osteonics Corp. directly.

Affected Products

TRIATHLON FEMORAL DISTAL AUGMENT 10MM - SIZE 2 RIGHT Catalog # 5541-A-202 - Product Usage: Triathlon Femoral Distal Augments are used with Triathlon TS Femoral Components during revision Total Knee Arthroplasty (TKA) and with Triathlon Primary PS Femoral Components during TKA to address distal femoral defects. (See attached IFU (IFU_Triathlon Total Knee_QIN 4376 Rev AB).

Quantity: 171 units

Why Was This Recalled?

Due to device overhang issue that protrudes beyond the medial periphery of the mating femoral component

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