BEUDAMED
    FDA Enforcement Class II Ongoing

    MEDLINE UNITE FOOT & ANKLE DRILL BIT, 1.3MM Solid Core, REF MPN10013

    Recall: Z-1047-2023 · Reported February 8, 2023

    Enforcement

    Recall Number
    Z-1047-2023
    Event ID
    91491
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    MEDLINE INDUSTRIES, LP - Northfield
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 8, 2023
    Initiation Date
    December 22, 2022
    Classification Date
    February 1, 2023
    Address
    3 Lakes Dr, N/A, Northfield, IL, 60093-2753, United States

    Description

    MEDLINE UNITE FOOT & ANKLE DRILL BIT, 1.3MM Solid Core, REF MPN10013

    Reason

    The recall is due to observed intra-operative screw failure. When pre-drilled with ¿1.3mm drill bit for ¿2.0mm screws and ¿1.6mm drill bit for ¿2.4mm we have observed screw failure due to excessive torque.

    Code Info

    GTIN 10888277699113, Lot Number ?

    Distribution

    US Nationwide distribution.

    Quantity

    190 units