BEUDAMED
    FDA Enforcement Class II Terminated

    Total Temporomandibular Joint Replacement System- 45mm Rt Narrow Ti Mand Reconstruction of the temporomandibular joint

    Recall: Z-0511-2015 · Reported December 17, 2014

    Enforcement

    Recall Number
    Z-0511-2015
    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- 45mm Rt Narrow 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 01-6545TI, Lot #s: 535380D, 531850A, 531850B, 531860A, 531860B, 535380B, 535380C, 535380A.

    Distribution

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

    Quantity

    42