Recall Z-2462-2026— Howmedica Osteonics Corp.

Name: FDA recall Z-2462-2026
Creator: U.S. Food and Drug Administration
Published: 2026-05-19

Class II · Ongoing

Class II FDA medical device recall by Howmedica Osteonics Corp., initiated 2026-05-19. It names one FDA 510(k) clearance: K123486. Product: TRI TS BASEPLATE SIZE 4. Part Number: 5521-B-400.. Reason: Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in packaging labeled as Triathlon Universal Baseplate Size 4 (lot TYX7OB), and Triathlon Universal Baseplate Size 4 (lot TYX7OB), is contained in packaging labeled as Triathlon Universal Baseplate Size 3, (lot UZD9IB)..

Recalling firm: Howmedica Osteonics Corp.
Classification: Class II
Status: Ongoing
Initiated: 2026-05-19
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

TRI TS BASEPLATE SIZE 4. Part Number: 5521-B-400.

Reason for recall

Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in packaging labeled as Triathlon Universal Baseplate Size 4 (lot TYX7OB), and Triathlon Universal Baseplate Size 4 (lot TYX7OB), is contained in packaging labeled as Triathlon Universal Baseplate Size 3, (lot UZD9IB).

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