BEUDAMED
    FDA Recall Terminated

    Tibila Insert UC, Balanced Knee System, REF163-3YYY Product Usage: UHMWPE component used in TKA procedures to serve as a tibial bearing surface for articulation with the femoral component

    Recall: Z-2256-2014 · Initiated July 11, 2014

    Recall

    Recall Number
    Z-2256-2014
    Event Number
    68898
    Firm
    Ortho Development Corporation
    FEI Number
    3017298928
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    July 11, 2014
    Posted
    August 17, 2014
    Terminated
    October 6, 2014
    Address
    12187 Business Park Dr, Draper, UT, 84020-8663

    Description

    Tibila Insert UC, Balanced Knee System, REF163-3YYY Product Usage: UHMWPE component used in TKA procedures to serve as a tibial bearing surface for articulation with the femoral component

    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.

    Action

    Ortho Development notified all affected consignees/distributors of the recall via email on July 11, 2014 which included a list of the affected product (part numbers, lot numbers and quantities) under their control. An RMA number and return shipping label were also included with the email. Emails were followed up with phone calls to verify receipt of the notification.

    Distribution

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

    Quantity

    13