Z-0761-2010

Triathlon Total Stabilizer Femoral Component; For Use with TS Components; Sterile, Made in the USA Stryker...

Name: Z-0761-2010 Triathlon Total Stabilizer Femoral Component; For Use with TS Components; Sterile, Made in the USA Stryker...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2009-12-10
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2009-12-10 / Terminated / root cause: manufacturing process

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Triathlon Total Stabilizer Femoral Component; For Use with TS Components; Sterile, Made in the USA Stryker Orthopaedics, Mahwah, NJ 07430. The Triathlon Total... on 2009-12-10. The reason FDA records is "Triathlon TS femoral components may have been damaged during manufacturing, possibly preventing the assembly of a stem extension". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0761-2010
Status: Terminated
Initiated: 2009-12-10
Posted: 2010-02-01
Terminated: 2012-08-28
Recalling firm: Howmedica Osteonics Corp
Product: Triathlon Total Stabilizer Femoral Component; For Use with TS Components; Sterile, Made in the USA Stryker Orthopaedics, Mahwah, NJ 07430. The Triathlon Total Knee System components are intended for use in primary and revision total knee arthroplasty to alleviate pain and restore function.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Triathlon TS femoral components may have been damaged during manufacturing, possibly preventing the assembly of a stem extension.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: An "Urgent Product Recall" Letter dated December 10, 2009 was sent by Federal Express to all Stryker Branches, Chief of Orthopaedics, Hospital Risk Management and Surgeons. The letter described the affected product, issue and potential hazards. Consignees were instructed to complete Product Recall Acknowledgement Form and return to Stryker Orthopaedics via fax at 1-201-831-6069. All questions regarding the recall should be directed to Stryker Orthopaedics at 1-201-972-2100.
Quantity in commerce: 9
Distribution: Worldwide Distribution -- United States (DE, NC, OH. MI, TX, CA, MA, NJ, TN, KS, GA, FL, AL, IN, MN, MD, NE, AR, OK, CO, AZ, OR, and MA), Australia, United Kingdom and Canada.
Product codes and lots: Catalog number: 5512-F-502; Lot codes: XDESR1 and XKWG.

Product code JWH

K070095Class IITriathlon Ts Knee SystemHowmedica Osteonics Corp. / cleared 2007-06-01

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)