BEUDAMED
    FDA Recall Terminated

    Stryker Orthopaedics Sterile Knee Instrument, Patella Cutter; Stainless Steel, Disposable; Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 33 mm size, One single unit to a package. Note: The 30 mm instruments were not distributed. The patella cutters are components of the Xcelerate Instruments and are used with additional devices to remove bone from the patella in preparation for a replacement implant. The Xcelerate Patella Reaming Instruments provide a means to prepare for implantation of either the Duracon or Scorpio Total Knee Systems patellar implants.

    Recall: Z-0529-2010 · Initiated November 11, 2009

    Recall

    Recall Number
    Z-0529-2010
    Event Number
    53858
    Firm
    Stryker Howmedica Osteonics Corp.
    FEI Number
    3003070421
    Product Code
    HTS
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    November 11, 2009
    Posted
    December 15, 2009
    Terminated
    August 30, 2010
    Address
    325 Corporate Drive, Mahwah, NJ, 07430

    Description

    Stryker Orthopaedics Sterile Knee Instrument, Patella Cutter; Stainless Steel, Disposable; Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 33 mm size, One single unit to a package. Note: The 30 mm instruments were not distributed. The patella cutters are components of the Xcelerate Instruments and are used with additional devices to remove bone from the patella in preparation for a replacement implant. The Xcelerate Patella Reaming Instruments provide a means to prepare for implantation of either the Duracon or Scorpio Total Knee Systems patellar implants.

    Reason

    Disposable Patella Cutters - 30 mm (catalog number 8000-0030, lot V31257001) were packaged and labeled as 33 mm Disposable Patella Cutters (catalog number 8000-0033, lot V31257001 and vice versa.

    Action

    An "Urgent Product Recall" letter dated November 11, 2009 was sent to all affected Stryker branches, hospital risk management, hospital Chief or Orthopaedics and surgeons by Federal Express. The letter described the issue, potential hazards and risk mitigation factors and requested that the Recall Acknowledgement form be completed and returned. The Recall Acknowledgement form has information regarding the return of affected product to the firm. Direct questions to Stryker Orthopaedics by calling 1-201-831-5832.

    Distribution

    Nationwide Distribution (MA, NJ, FL, TN, OR and NY).

    Quantity

    12