BEUDAMED
    FDA Enforcement Class II Terminated

    Mac Pin Non-Cannulated Screw, 6.5 x 60mm

    Recall: Z-0325-2018 · Reported January 17, 2018

    Enforcement

    Recall Number
    Z-0325-2018
    Event ID
    77991
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Amendia, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 17, 2018
    Initiation Date
    July 7, 2017
    Classification Date
    January 10, 2018
    Termination Date
    October 15, 2019
    Address
    1755 W Oak Pkwy, N/A, Marietta, GA, 30062-2260, United States

    Description

    Mac Pin Non-Cannulated Screw, 6.5 x 60mm

    Reason

    Incorrect labeling for the lot of MAC Pins. Although the pins are laser as 460 mm in length, the pins are 60 mm in length.

    Code Info

    Model #85-6560-1, Lot #132117

    Distribution

    Distribution to Georgia, USA.

    Quantity

    41 screws