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 PS X3 Tibial Insert Recalled by Stryker Howmedica Osteonics Corp. Due to Stryker Orthopaedics received a report that 5537-G-319 No...

Date: May 29, 2015
Company: Stryker 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 Stryker Howmedica Osteonics Corp. directly.

Affected Products

Triathlon PS X3 Tibial Insert; No. 3 Triathlon TS Plus Tibial Insert X3 Poly 19 mm Product Usage: The Triathlon PS X3 (posterior stabilized), cat no 5532-G-xxx and X3 TS (total stabilizing) Plus, cat. no. 5537-G-XXX, Tibial Inserts are used in TKA surgeries. During surgery, the tibial insert is locked into the tibial baseplate where it serves as the bearing component for the articulating surface of a corresponding Triathlon femoral component.

Quantity: 26 units

Why Was This Recalled?

Stryker Orthopaedics received a report that 5537-G-319 No 3. Triathlon TS Plus Tibial Insert X3 Poly 19 mm i insert was in a package labeled as a 5532-G-511 Triathlon PS Stibialism Insert.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp. has 87 total recalls tracked by RecallDetector.

Related Recalls

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