BEUDAMED
    FDA Enforcement Class II Terminated

    Total Temporomandibular Joint Replacement System- 55mm Lft Standard Ti Mand Reconstruction of the temporomandibular joint

    Recall: Z-0519-2015 · Reported December 17, 2014

    Enforcement

    Recall Number
    Z-0519-2015
    Event ID
    69644
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biomet Microfixation, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 17, 2014
    Initiation Date
    October 17, 2014
    Classification Date
    December 8, 2014
    Termination Date
    January 4, 2017
    Address
    1520 Tradeport Dr, N/A, Jacksonville, FL, 32218-2480, United States

    Description

    Total Temporomandibular Joint Replacement System- 55mm Lft Standard Ti Mand Reconstruction of the temporomandibular joint

    Reason

    Laser etching on the parts is wider and deeper than the conditions previously validated.

    Code Info

    Model 24-6556TI, Lot #s: 520240A, 520230A, 550400A, 550390B, 520230B, 520240B, 535400B, 550400B, 535400A, 535410A, 535410B, 550370A, 550370B, 550380A, 550380B, 550390A.

    Distribution

    Worldwide Distribution - USA including PA, MN, CA and Internationally to Australia, Netherlands, France, and United Kingdom.

    Quantity

    42