BEUDAMED
    FDA Recall Terminated

    Mac Pin Non-Cannulated Screw, 6.5 x 60mm

    Recall: Z-0325-2018 · Initiated July 7, 2017

    Recall

    Recall Number
    Z-0325-2018
    Event Number
    77991
    Firm
    Amendia, Inc
    FEI Number
    3007970248
    Product Code
    NKB
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    July 7, 2017
    Terminated
    October 15, 2019
    Address
    1755 W Oak Pkwy, Marietta, GA, 30062-2260

    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.

    Action

    Customers were sent recall notification letters on 07/07/2017. Instructions included to examine inventory and quarantine affected products, notify customers if affected products were further distributed, coordinate the return of affected products back to Amendia, and to complete and return the questionnaire. If there are questions, Amendia Customer Service can be contacted at 770-575-5224.

    Distribution

    Distribution to Georgia, USA.

    Quantity

    41 screws