Howmedica Osteonics Corp.: Medical Device Recall in 2023 - (Recall #: Z-1653-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM-Intended for knee replacement Catalog Number: 5531-G-312-E

Product Classification:

Class II

Date Initiated: April 13, 2023

Date Posted: June 7, 2023

Recall Number: Z-1653-2023

Event ID: 92257

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

Status: Ongoing

Product Quantity: 24 units in total

Code Information:

GTIN: 07613327390698 Lot Number: JH3AHJ

Distribution Pattern:

US Nationwide - Worldwide Distribution: CT, FL, IN, KY, MT, NJ, OR, PA, SC Foreign: China, Japan

Voluntary or Mandated:

Voluntary: Firm initiated