Recall Z-0023-2025— Howmedica Osteonics Corp.

Name: FDA recall Z-0023-2025
Creator: U.S. Food and Drug Administration
Published: 2024-09-04

Class II · Ongoing

Class II FDA medical device recall by Howmedica Osteonics Corp., initiated 2024-09-04. It names one FDA 510(k) clearance: K141056. Product: Triathlon Universal TS Baseplate Size 2 - A single use sterile implantable device intended for cemented applications during primary and revision Total Knee Arthroplasty (TKA) when the Triathlon Knee System is selected for use. Catalog Number: 5521-B-200. Reason: Anterior locking tabs on the Triathlon Universal Baseplate are out of specification which may prevent engagement of either of the two locking tabs with the locking wire of the tibial insert..

Recalling firm: Howmedica Osteonics Corp.
Classification: Class II
Status: Ongoing
Initiated: 2024-09-04
Firm location: Mahwah, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K141056 — TRIATHLON KNEE SYSTEM POSTERIOR STABILIZED COMPONENTSStryker Orthopaedics·cleared 2014-08-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Triathlon Universal TS Baseplate Size 2 - A single use sterile implantable device intended for cemented applications during primary and revision Total Knee Arthroplasty (TKA) when the Triathlon Knee System is selected for use. Catalog Number: 5521-B-200

Reason for recall

Anterior locking tabs on the Triathlon Universal Baseplate are out of specification which may prevent engagement of either of the two locking tabs with the locking wire of the tibial insert.

Data sourced from openFDA. This site is unofficial and independent of the FDA.