Z-2789-2016 Class II Terminated
FDA device recall Z-2789-2016 was initiated by Stryker Howmedica Osteonics Corp. on August 1, 2016 and is designated Class II. Reason for recall: Upon failure of the press-fit, the clamping sub components and pins could disassociate from the Scorpio Patella Assembly Instrument. The recall status is terminated (terminated June 8, 2017). Affected quantity: 2,039 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 21, 2016
- Initiation Date
- August 1, 2016
- Termination Date
- June 8, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,039 units
Product Description
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.
Reason for Recall
Upon failure of the press-fit, the clamping sub components and pins could disassociate from the Scorpio Patella Assembly Instrument.
Distribution Pattern
US Nationwide and Internationally
Code Information
Catalog No. 3182-1000 Lot #'s: RD8E100, RD8A054TT, RD8A054T, RD8E099M, RD8E099A, RD8E099, RD8A054A, RD8E099D, RD8A053A, RD8A054, RD8A053T, RD7K062L, RD8A052A, RD8A052E, RD8A052, RD8A053, RD7E128D, RD5T290H, RD7E128T, RD5S262D, RD5T290W, RD7K062E, RD5S262X, RD7E128Y, RD7A076MA, RD6W102MA, RD7K062A, RD7K062, RD7E128H, RD7A076A, RD7E128A, RS7E128, RD6W103D, RD6V108J, RD6V108K, RD6V108H, RD7A076H, RD6V112M, RD7A074D, RD7A076J, RD6V112H, RD6W102m, RD5H286A, RD2V022, RD2K049, RD6W103, RD5H286J, RD2T037A, RD7A076M, RD6S136A, RD5H286, RD2V031C, RD5N361T, RD6V112A, RD4M068J, RD2V021C, RD7A076, RD6V112, RD4E226W, RD2V021, RD7A074H, RD6W102, RD4S220W, RD2V023X2, RD6W103A, RD6S136M, RD4M069D, RD2V023X3, RD6V108, RD5W148M, RD4S220, RD2V023, RD7A074, RD5M237K, RD4S220A, RD2V031A, RD7A074A, RD5T290X, RD4S220A1, RD2V023X1, RD6W103M, RD5T290A, RD4M069, RD2V031, RD5K116A, RD6S137A, RD4L128X1, RD2V031X2, RD5M236T, RD5W148A, RD4L128V, RD2V031X1, RD5K116T, RD6S137, RD4E226J, RD2N030K, RD3V002A, RD6S136, RD4M068< RD2T037, RD5M237, RD5W148X, RD4L128, RD2T037X, RD5K116N, RD5W148, RD4E226M, RD2N030E, RD5K116, RD5T290M, RD4E226L1, RD2N030S, RD5M236, RD5T290E, RD4C230L, RD2N030X, RD5H286L, RD5T290, RD4E226L, RD2N030XX, RD3T155L, RD5T290D, RD4E226, RD2N030, RD2V021E, RD5N361A, RD4C162L, RD2K068W, RD2V022W, RD5S305J, RD4C162, RD2N030X1, RD2V021S, RD5S305M, RD4C230, RD2M019E, RD2V022K, RD5N361M, RD4C230X, RD2M039, RD2V022E, RD5S305, RD3V002P, RD2M019H, RD2V021H, RD5S262A, RD3V002X1, RD2K049H, RD2V023E, RD5S262M1, RD3V002X2, RD2M003H, RD2T037W, RD5S262M, RD3V002D1, RD2M038H, RD2K068X1, RD5S262J, RD3V002, RD2K068B, RD2K068, RD5S262, RD3V002D, RD2M003, RD2K049R, RD5N361H, RD3V206D, RD2M038, RD2K049E, RD5M259M, RD3T160L1, RD2M019, RD2K017E, RD5N316, RD3V206X1, RD2K068S, RD2H056, RD5H286D, RD3T155L1, RD2K056S, RD2K056, RD5M259T, RD3T160L3, RD2K065S, RD2K065, RD5M236H, RD3T160, RD2K049S, RD2K017, RD5M259, RD3T160L2, RD2K068E, RD5M237L, RD3T160L, RD2H056E, RD5K116J, RD3V206, RD2K065E, RD4S220D, RD3T155 and RD2K056E