BEUDAMED
    FDA Recall Terminated

    UltraCongruent Tibial Insert Model 0214703 Tibial Insert, Ultra-Congruent, Right, Size 3, 10mm

    Recall: Z-0540-05 · Initiated January 4, 2005

    Recall

    Recall Number
    Z-0540-05
    Event Number
    30807
    Firm
    Plus Orthopedics
    FEI Number
    3001237832
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 4, 2005
    Posted
    February 15, 2005
    Terminated
    March 3, 2005
    Address
    10188 Telesis Ct, San Diego, CA, 92121

    Description

    UltraCongruent Tibial Insert Model 0214703 Tibial Insert, Ultra-Congruent, Right, Size 3, 10mm

    Reason

    Knee tibial insert is mislabeled completely as different device.

    Action

    PLUS Orthopedics QA department has identified a labeling eror on Article 0214703, affecting lot number 044843. This Ultra-congruent PE insert package may contain a Standard PE insert.

    Distribution

    California, Idaho, Illinois, Wisconsin, Oregon

    Quantity

    10, 1 is implanted.