BEUDAMED
    FDA Recall Terminated

    Turon Impaction Fixture

    Recall: Z-1412-2017 · Initiated February 9, 2017

    Recall

    Recall Number
    Z-1412-2017
    Event Number
    76456
    FEI Number
    1000116912
    Product Code
    HWA
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    February 9, 2017
    Terminated
    October 20, 2017
    Address
    9800 Metric Blvd, Encore Medical, Lp, Austin, TX, 78758-5445

    Description

    Turon Impaction Fixture

    Reason

    During the Turon assembly, the impaction forces caused the polymer, black acetal copolymer from the Impaction Fixture to wear off on the lateral surface of the Humeral Stem titanium plasma spray coating.

    Action

    There are two field safety notices, one for Consignees who have surgeons that use the impaction fixtures (Verson 1) and one for Consignees who had previously indicated their surgeons do NOT use the impaction fixtures (Verson 2). The two recall notification letters were sent out on 2/9/17.

    Distribution

    US, South Korea, Australia, Canada, United Kingdom/Ireland, Germany

    Quantity

    297 units