BEUDAMED
    FDA Enforcement Class II Ongoing

    EMPOWR Partial Knee Peg Drill Guide; Model: 800-06-007.

    Recall: Z-0479-2021 · Reported December 2, 2020

    Enforcement

    Recall Number
    Z-0479-2021
    Event ID
    85943
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Encore Medical, LP
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 2, 2020
    Initiation Date
    June 19, 2020
    Classification Date
    November 20, 2020
    Address
    9800 Metric Blvd, N/A, Austin, TX, 78758-5445, United States

    Description

    EMPOWR Partial Knee Peg Drill Guide; Model: 800-06-007.

    Reason

    There have been issues experienced with the peg preparation steps, specifically drilling of the Femoral posterior peg. Upon drilling, the shaft portion of the drill may bind within the Posterior Peg drill guide. The extended length of the drill guide and tight tolerances to ensure accurate preparation seem to be contributing to this situation. There is a potential of a delay in surgery if this issue were to recur.

    Code Info

    all lot numbers

    Distribution

    US: AZ, CA, FL, GA, IL, IN, MI, MN, NY, TX, VA, and WA.. No OUS Consignees.

    Quantity

    28 units