BEUDAMED
    FDA Recall Terminated

    Offset Femoral Alignment Guide 4mm x 6; Product Code: KS 67024 Product Usage: The instrumentation has been designed to facilitate bone preparation and implantation of the Apex Knee or Apex Hip Systems. Product Usage: The instrumentation has been designed to facilitate bone preparation and implantation of the Apex Knee or Apex Hip Systems

    Recall: Z-2455-2015 · Initiated June 9, 2015

    Recall

    Recall Number
    Z-2455-2015
    Event Number
    71470
    Firm
    Omnilife Science Inc.
    FEI Number
    3008342029
    Product Code
    FZX
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    June 9, 2015
    Posted
    August 24, 2015
    Terminated
    September 28, 2015
    Address
    50 Oconnell Way, Ste 10, East Taunton, MA, 02718-1394

    Description

    Offset Femoral Alignment Guide 4mm x 6; Product Code: KS 67024 Product Usage: The instrumentation has been designed to facilitate bone preparation and implantation of the Apex Knee or Apex Hip Systems. Product Usage: The instrumentation has been designed to facilitate bone preparation and implantation of the Apex Knee or Apex Hip Systems

    Reason

    The markings on both versions of the OFFSET FEMORAL ALIGNMENT GUIDES are incorrect. Specifically, the markings on the alignment guides are reversed from the intended position that should provide proper alignment for the offset revision stems when used with the femur.

    Action

    Omni sent an Urgent Medical Device -Field Safety Notice letters to their customers. The letter identifed the affected product, problem and actions to be taken. Customers were instructed to Return the attached Acknowledgement and Receipt Form by FAX to 508-819-3390.

    Distribution

    Worldwide Distribution - US Nationwide in the states of OK, CO, OH, MA and the countries of Spain and Australia.

    Quantity

    15