Recalls / —
—#120779
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.
- FDA product code
- GDJ — Clamp, Surgical, General & Plastic Surgery
- Device class
- Class 1
- Medical specialty
- General, Plastic Surgery
- Affected lot / code info
- Catalog #6541-2-609 All lot codes
Why it was recalled
Cracks or fracture of the Triathlon Tibial Alignment Ankle Clamp, an instrument.
Root cause (FDA determination)
Device Design
Action the firm took
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.
Recalling firm
- Firm
- Stryker Howmedica Osteonics Corp.
- Address
- 325 Corporate Dr, Mahwah, New Jersey 07430-2002
Distribution
- Distribution pattern
- Nationwide Distribution
Timeline
- Recall initiated
- 2013-07-02
- Posted by FDA
- 2013-08-29
- Terminated
- 2016-04-27
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #120779. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.