FDA-Device2016-09-21Class II
Stryker Orthopaedics Patella Assembly Instrument, REF 3182-1000, Non-Sterile, NDC (01) 07613327215854 (10) The Scorpio Patella Assembly Instrument is used during total knee replacement surgery for the implantation of Scorpio Patella implant components. The device functions to fully seat the implant onto the bone and secure it in position while the surgeon removes any excess cement and when cement polymerization occurs.
Stryker Howmedica Osteonics Corp.
Hazard
Upon failure of the press-fit, the clamping sub components and pins could disassociate from the Scorpio Patella Assembly Instrument.
Sold states
US Nationwide and Internationally
Affected count
2,039 units
Manufactured in
325 Corporate Dr, N/A, Mahwah, NJ, United States
Products
Stryker Orthopaedics Patella Assembly Instrument, REF 3182-1000, Non-Sterile, NDC (01) 07613327215854 (10) The Scorpio Patella Assembly Instrument is used during total knee replacement surgery for the implantation of Scorpio Patella implant components. The device functions to fully seat the implant onto the bone and secure it in position while the surgeon removes any excess cement and when cement polymerization occurs.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2789-2016Don't want to check this manually?
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