BEUDAMED
    FDA Enforcement Class II Ongoing

    MEDLINE UNITE FOOT & ANKLE Screw, Polyaxial Locking, Mini T8 (2.0x8mm), REF MMSL2008

    Recall: Z-1046-2023 · Reported February 8, 2023

    Enforcement

    Recall Number
    Z-1046-2023
    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 Screw, Polyaxial Locking, Mini T8 (2.0x8mm), REF MMSL2008

    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 10193489120707, Lot Number 810304

    Distribution

    US Nationwide distribution.

    Quantity

    420 units