Recall Z-1261-2024— Howmedica Osteonics Corp.

Name: FDA recall Z-1261-2024
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: X3 TRIATHLON CS INSERT NO 6 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

X3 TRIATHLON CS INSERT NO 6 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.