Z-2130-2013Class II

Stryker Howmedica Osteonics Triathlon tibial alignment ankle clamp extramedullary (EM) referencing instrument...

Name: Z-2130-2013 Stryker Howmedica Osteonics Triathlon tibial alignment ankle clamp extramedullary (EM) referencing instrument...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2013-07-02
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2013-07-02 / Terminated / root cause: design

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Stryker Howmedica Osteonics Triathlon tibial alignment ankle clamp extramedullary (EM) referencing instrument (Cat. No. 6541-2-609), for use in Total Knee... on 2013-07-02. FDA classified it as Class II and gives the reason as "Cracks or fracture of the Triathlon Tibial Alignment Ankle Clamp, an instrument". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2130-2013
Classification: Class II
Status: Terminated
Initiated: 2013-07-02
Posted: 2013-08-29
Terminated: 2016-04-27
Recalling firm: Howmedica Osteonics Corp
Product: Stryker Howmedica Osteonics Triathlon tibial alignment ankle clamp extramedullary (EM) referencing instrument (Cat. No. 6541-2-609), for use in Total Knee Arthroplasty (TKA) when the surgeon elects to use Stryker's Triathlon Total Knee System in conjunction with EM referencing. Non-Sterile Instrument.
Product code: GDJ Clamp, Surgical, General & Plastic Surgery
Reason for recall: Cracks or fracture of the Triathlon Tibial Alignment Ankle Clamp, an instrument.
Root cause tag: design
FDA root cause: Device Design
Action: Stryker Orthopaedics sent an Urgent Medical Device Correction letter dated July 2, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by t he customers. Customers are advised of the issue, potential hazards and risk mitigation factors. Customers are asked to complete the attached form and fax to 855-251-3635. Any questions should be directed to (201) 972-2100. All letters included a Product Correction Bulletin.
Quantity in commerce: 10,537 units
Distribution: Nationwide Distribution
Product codes and lots: Catalog #6541-2-609 All lot codes

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2130-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2130-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-04	2013-08-29

Product code GDJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)