BEUDAMED
    FDA Recall Open, Classified

    Flexible Drill Shaft, FMP Acetabular System Instrumentation REF 803-05-239 RX Encore Medical, L.P.

    Recall: Z-2090-2019 · Initiated September 19, 2018

    Recall

    Recall Number
    Z-2090-2019
    Event Number
    83037
    FEI Number
    1000116912
    Product Code
    HWE
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    September 19, 2018
    Address
    9800 Metric Blvd, Encore Medical, Lp, Austin, TX, 78758-5445

    Description

    Flexible Drill Shaft, FMP Acetabular System Instrumentation REF 803-05-239 RX Encore Medical, L.P.

    Reason

    Manufacturing error, the drill bit shaft is unable to properly capture the drill bit pin. Failure of the drill bit shaft to capture the drill bit pin could result in the drill bit coming loose which could result in a delay in surgery or adverse patient reaction resulting in a revision surgery.

    Action

    On 9/19/2018 the firm emailed an "Urgent Field Safety Notice" letter to their consignees. The Field Safety Notice letter asked the customers to do the following: 1.Contact their customer service to request a RMA for return and exchange. 2.If the customer does not have the drill shaft or the number of sets identified, please contact Joan Busick at [email protected]. 3. If the customer has questions they should contact Teffany Hutto by phone at (512) 834-6255.

    Distribution

    US ( MS, NY, MO, OK, UT, AZ)

    Quantity

    21