BEUDAMED
    FDA Enforcement Class II Terminated

    Total Temporomandibular Joint Replacement System- 50mm Rt Standard Ti Mand Reconstruction of the temporomandibular joint

    Recall: Z-0517-2015 · Reported December 17, 2014

    Enforcement

    Recall Number
    Z-0517-2015
    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- 50mm Rt 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 24-6650TI, Lot #s: 518480B, 518480A, 525970A, 525970B, 525980B, 518490A, 526070A, 525990A, 525990B, 526060A, 526060B, 526070B, 525980A, 550330A, 550330B, 550340A, 550340B, 550350A, 550360A, 550360B, 518490B, 525960A, 525960B,

    Distribution

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

    Quantity

    42