Home / Recalls / Stryker Howmedica Osteonics Corp. / Z-2789-2016

Z-2789-2016 Class II Terminated

Recalled by Stryker Howmedica Osteonics Corp. — Mahwah, NJ

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

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