FDA-Device2015-03-25Class II
Triathlon Distal Capture Assembly Catalog No: 6541-1-723 The Triathlon Distal Capture Assembly is used when a surgeon elects to use a capture for the distal femoral resection or proximal tibial resection in a Triathlon primary total knee arthroplasty (TKA).
Stryker Howmedica Osteonics Corp.
Hazard
Potential for weld disassociation of the cross pin, which could lead to loose or disassociated trigger mechanism on the Distal Capture Assembly.
Sold states
Worldwide Distribution - USA (nationwide) Puerto Rico, and Internationally to Canada, Hong Kong, Netherlands, Sweden, Switzerland, Spain, France, Italy, UK, India, Australia, Korea, Panama, Polan, Ireland, Kuala Lumpar, New Zealand and South Africa.
Affected count
2030 units
Manufactured in
325 Corporate Dr, Mahwah, NJ, United States
Products
Triathlon Distal Capture Assembly Catalog No: 6541-1-723 The Triathlon Distal Capture Assembly is used when a surgeon elects to use a capture for the distal femoral resection or proximal tibial resection in a Triathlon primary total knee arthroplasty (TKA).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1283-2015Don't want to check this manually?
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