Recall Z-2130-2013 ยท GDJ Clamp, Surgical, General & Plastic Surgery
Stryker Howmedica Osteonics Corp.
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.
| Date | Aug 29, 2013 (initiated Jul 2, 2013) |
| Status | Terminated |
| Reason | Cracks or fracture of the Triathlon Tibial Alignment Ankle Clamp, an instrument. |
| 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 | 10,537 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.