Recall Z-1237-2022— Howmedica Osteonics Corp.

Name: FDA recall Z-1237-2022
Creator: U.S. Food and Drug Administration
Published: 2022-03-30

Class II · Ongoing

Class II FDA medical device recall by Howmedica Osteonics Corp., initiated 2022-03-30. It names one FDA 510(k) clearance: K123486. Product: Triathlon Tritanium Tibial Component (Size 6); Catalog Number 5536-B-600 Triathlon¿ Tritanium¿ Tibial Component (Size 5); Catalog Number 5536-B-500. Reason: Stryker has discovered a potential product mix where the size of the Triathlon Tritanium Tibial Component inside the package does not match the package labeling..

Recalling firm: Howmedica Osteonics Corp.
Classification: Class II
Status: Ongoing
Initiated: 2022-03-30
Firm location: Mahwah, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K123486 — TRIATHLON TRITANIUM TIBIAL BASEPLATEStryker·cleared 2013-05-03

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 Tritanium Tibial Component (Size 6); Catalog Number 5536-B-600 Triathlon¿ Tritanium¿ Tibial Component (Size 5); Catalog Number 5536-B-500

Reason for recall

Stryker has discovered a potential product mix where the size of the Triathlon Tritanium Tibial Component inside the package does not match the package labeling.

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