Device 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.
Z-2130-2013
Product summary
- Event
- Event 65902
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10,537 units
- Official record key
device-enforcement:Z-2130-2013
Official wording
Reason: Cracks or fracture of the Triathlon Tibial Alignment Ankle Clamp, an instrument.
Code information: Catalog #6541-2-609 All lot codes
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Unknown
Cracks or fracture of the Triathlon Tibial Alignment Ankle Clamp, an instrument.