BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0517-2015 · Initiated October 17, 2014

    Recall

    Recall Number
    Z-0517-2015
    Event Number
    69644
    Firm
    Biomet Microfixation, LLC
    FEI Number
    1032347
    Product Code
    LZD
    Status
    Terminated
    Root Cause
    Software Design Change
    Initiated
    October 17, 2014
    Posted
    December 16, 2014
    Terminated
    January 4, 2017
    Address
    1520 Tradeport Dr, Jacksonville, FL, 32218-2480

    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.

    Action

    BIOMET sent an Urgent Medical Device Recall letter dated October 17, 2014 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to take the following steps: 1) Immediately locate and remove from circulation the items invoiced/consigned/loaned to your account. 2) Carefully follow the instructions on the enclosed "Response Form." and 3)If you have further distributed these items to medical facilities, you must notify them of this action. For questions customers were instructed to call 1-800-874-7711 or 904-741-4400, extension 9448, Monday through Friday, 8 a.m. to 4 p.m. EST. For questions regarding this recall call 904-741-9448.

    Distribution

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

    Quantity

    42