FDA-Device2013-09-04Class II
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.
Stryker Howmedica Osteonics Corp.
Hazard
Cracks or fracture of the Triathlon Tibial Alignment Ankle Clamp, an instrument.
Sold states
Nationwide Distribution
Affected count
10,537 units
Manufactured in
325 Corporate Dr, Mahwah, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2130-2013Don't want to check this manually?
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