BEUDAMED
    FDA Recall Terminated

    Apex Knee System, Tibial Baseplate Size 6 Left, non-porous - KC-2206L The Apex Knee System is intended for use as a primary or revision total knee replacement. This knee replacement system is intended for cemented fixation and single use implantation. This prosthesis may be used for the following conditions, as appropriate: Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; Rheumatoid arthritis; Correction of functional deformity; Revision procedures where other treatments or devices have failed.

    Recall: Z-1117-2018 · Initiated November 20, 2017

    Recall

    Recall Number
    Z-1117-2018
    Event Number
    79268
    Firm
    OMNIlife science Inc.
    FEI Number
    3008342029
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Incorrect or no expiration date
    Initiated
    November 20, 2017
    Terminated
    June 7, 2019
    Address
    480 Paramount Dr, Raynham, MA, 02767-1085

    Description

    Apex Knee System, Tibial Baseplate Size 6 Left, non-porous - KC-2206L The Apex Knee System is intended for use as a primary or revision total knee replacement. This knee replacement system is intended for cemented fixation and single use implantation. This prosthesis may be used for the following conditions, as appropriate: Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; Rheumatoid arthritis; Correction of functional deformity; Revision procedures where other treatments or devices have failed.

    Reason

    The Apex Knee System Tibial Baseplate identified has an improper expiration date marked on the external packaging. The improper expiration date (2202-03) is marked on the external packaging only. The correct lot number (2022-03) is present in the internal packaging and sterile batch documentation.

    Action

    OMNIlife science, Inc. sent an Urgent Medical Device Advisory Notice dated November 20, 2017. Actions to be taken by the Customer/User "Immediately quarantine lot 26519 for KC-2206L "Return Product Using RMA# XXXX to OMNI. "This advisory notice only includes LOT 26519. It does not affect other lots. You must acknowledge this notice by returning the attached Acknowledgement and Receipt Form and accompanying by FAX to 508-819-3390 or my email to [email protected]. For further questions, please call (508) 824-2444.

    Distribution

    Worldwide Distribution - US Distribution and to the country Spain.

    Quantity

    32