BEUDAMED
    FDA Enforcement Class II Ongoing

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

    Recall: Z-2090-2019 · Reported August 7, 2019

    Enforcement

    Recall Number
    Z-2090-2019
    Event ID
    83037
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Encore Medical, Lp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 7, 2019
    Initiation Date
    September 19, 2018
    Classification Date
    July 27, 2019
    Address
    9800 Metric Blvd, N/A, Austin, TX, 78758-5445, United States

    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.

    Code Info

    Lot # 262667L01

    Distribution

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

    Quantity

    21