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Terminated

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.

FDA Recall Z-2130-2013 · Posted 2013-08-29

Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeGDJ
Date Initiated2013-07-02
Date Terminated2016-04-27
Product Quantity10,537 units

Reason for Recall

Cracks or fracture of the Triathlon Tibial Alignment Ankle Clamp, an instrument.

Firm 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.

Root Cause

Device Design

Distribution Pattern

Nationwide Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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