BEUDAMED
    FDA Enforcement Class II Terminated

    SMR allen wrench 5 mm, product code 9013.50.210

    Recall: Z-2707-2016 · Reported September 7, 2016

    Enforcement

    Recall Number
    Z-2707-2016
    Event ID
    74827
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Limacorporate S.p.A
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 7, 2016
    Initiation Date
    July 21, 2016
    Classification Date
    August 31, 2016
    Termination Date
    January 13, 2017
    Address
    Via Nazionale 52, N/A, San Daniele Del Friuli, N/A, N/A, Italy

    Description

    SMR allen wrench 5 mm, product code 9013.50.210

    Reason

    Product found to be dimensionally non-conforming (slightly over dimensioned on the diameter of the Zimmer connection) and non-functional for connecting with some T-handles.

    Code Info

    14AA311

    Distribution

    US, Italy, Australia

    Quantity

    76