Z-1237-2022Class II

Triathlon Tritanium Tibial Component (Size 6); Catalog Number 5536-B-600 Triathlon Tritanium Tibial Component...

Name: Z-1237-2022 Triathlon Tritanium Tibial Component (Size 6); Catalog Number 5536-B-600 Triathlon Tritanium Tibial Component...
Creator: Howmedica Osteonics Corp.
Published: 2022-03-30
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2022-03-30 / Open, Classified / root cause: labeling and UDI

FDA source

Howmedica Osteonics Corp. began a recall of Triathlon Tritanium Tibial Component (Size 6); Catalog Number 5536-B-600 Triathlon Tritanium Tibial Component (Size 5); Catalog Number 5536-B-500 on 2022-03-30. FDA classified it as Class II and gives the reason as "Stryker has discovered a potential product mix where the size of the Triathlon Tritanium Tibial Component inside the package does not match the package labeling". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1237-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-03-30
Posted: 2022-06-03
Recalling firm: Howmedica Osteonics Corp
Product: Triathlon Tritanium Tibial Component (Size 6); Catalog Number 5536-B-600 Triathlon Tritanium Tibial Component (Size 5); Catalog Number 5536-B-500
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Stryker has discovered a potential product mix where the size of the Triathlon Tritanium Tibial Component inside the package does not match the package labeling.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: On March 30, 2022, the firm sent Urgent Medical Device Recall letters to affected customers. Customers were instructed to immediately identify, quarantine, and discontinue use of any affected devices in their facility. Customers should return the devices back to Stryker. If you have any questions or concerns regarding this recall, please contact Customer Service at (201) 831-5000. For questions pertaining to the recall, email [email protected]. ***Updated 6/6/22*** On June 6, 2022, the firm sent an updated letter to affected customers. The update letter includes the hazards, harms, and risk mitigation.
Quantity in commerce: 22 units (12 US; 10 OUS)
Distribution: Worldwide distribution - US Nationwide in the states of AL, CA, CO, ID, IN, KS, MI, NV, PA, TN, WA, and WV. The countries of UK and Poland.
Product codes and lots: Catalog Number UDI-DI (GTIN) Lots 5536-B-600 07613327041514 CTD69463 5536-B-500 07613327041507 CTD69106

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1237-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1237-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-06-15	2022-06-03

Product code JWH

K123486Class IITriathlon Tritanium Tibial BaseplateStryker / cleared 2013-05-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)