Recall Z-1654-2023— Howmedica Osteonics Corp.

Name: FDA recall Z-1654-2023
Creator: U.S. Food and Drug Administration
Published: 2023-04-13

Class II · Ongoing

Class II FDA medical device recall by Howmedica Osteonics Corp., initiated 2023-04-13. It names one FDA 510(k) clearance: K172634. Product: TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM Intended for knee replacement Catalog Number: 5532-G-413-E. Reason: Mislabeled:Labeled Catalog Number: 5531-G-312-E, TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM, may contain Catalog Number: 5532-G-413-E, TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM, and vice versa.

Recalling firm: Howmedica Osteonics Corp.
Classification: Class II
Status: Ongoing
Initiated: 2023-04-13
Firm location: Mahwah, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K172634 — Triathlon® X3® UHMWPE Tibial Inserts and Patellar ComponentsHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics·cleared 2017-11-16

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 X3 TIBIAL BEARING INSERT PS #4 13MM Intended for knee replacement Catalog Number: 5532-G-413-E

Reason for recall

Mislabeled:Labeled Catalog Number: 5531-G-312-E, TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM, may contain Catalog Number: 5532-G-413-E, TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM, and vice versa

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