BEUDAMED
    FDA Enforcement Class II Terminated

    Tibila Insert CK, Balanced Knee System Revision, REF563-1YYY Product Usage: UHMWPE component used in TKA and revision TKA procedures to serve as a tibial bearing surface for articulation with the femoral component where additional joint constraint is needed

    Recall: Z-2257-2014 · Reported August 27, 2014

    Enforcement

    Recall Number
    Z-2257-2014
    Event ID
    68898
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ortho Development Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 27, 2014
    Initiation Date
    July 11, 2014
    Classification Date
    August 17, 2014
    Termination Date
    October 6, 2014
    Address
    12187 Business Park Dr, Draper, UT, 84020-8663, United States

    Description

    Tibila Insert CK, Balanced Knee System Revision, REF563-1YYY Product Usage: UHMWPE component used in TKA and revision TKA procedures to serve as a tibial bearing surface for articulation with the femoral component where additional joint constraint is needed

    Reason

    Ortho Development is recalling various Pivot Bipolar Cup, Patella, PS Tibial Insert, UC Tibila Insert, and CK Tibil Insert because the foil pouches did not properly seal, allowing air to seep back into the pouch after sealing which increases the risk that the material properties of the implant would be substantially degraded due to oxidation.

    Code Info

    CK Tibial Insert Sz 6 12mm Part 563-1612, Lot A135666

    Distribution

    Worldwide Distribution - US Nationwide and the country of Japan. No military/govt/VA consignees.

    Quantity

    1