BEUDAMED
    FDA Recall Terminated

    17 mm thickness only of a polyethelene insert, which sits on the top of a metal component tibial implant. Part of the ''RT/RT Modular'' total knee replacement.

    Recall: Z-0107-04 · Initiated August 1, 2003

    Recall

    Recall Number
    Z-0107-04
    Event Number
    27053
    Firm
    Plus Orthopedics
    FEI Number
    3001237832
    Product Code
    KRO
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 1, 2003
    Posted
    November 13, 2003
    Terminated
    December 12, 2004
    Address
    6055 Lusk Blvd, San Diego, CA, 92121

    Description

    17 mm thickness only of a polyethelene insert, which sits on the top of a metal component tibial implant. Part of the ''RT/RT Modular'' total knee replacement.

    Reason

    Plastic insert over articular surface of knee joint replacement may become dislodged.

    Action

    Firm telephoned each distributor to ensure that devices were not used in upcoming surgeries on 8/1 or 8/26/2003.

    Distribution

    AZ, ID, TX CTdistributors.

    Quantity

    35