Recall Z-1264-2024— Howmedica Osteonics Corp.

Name: FDA recall Z-1264-2024
Creator: U.S. Food and Drug Administration
Published: 2024-02-06

Class II · Ongoing

Class II FDA medical device recall by Howmedica Osteonics Corp., initiated 2024-02-06. It names one FDA 510(k) clearance: K172634. Product: NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM. Reason: Potential packaging breaches of inner blister and outer sterile blister..

Recalling firm: Howmedica Osteonics Corp.
Classification: Class II
Status: Ongoing
Initiated: 2024-02-06
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

NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM

Reason for recall

Potential packaging breaches of inner blister and outer sterile blister.

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