BEUDAMED
    FDA Recall Terminated

    REF 200068 Security (TM) Enclosed Carpal Tunnel System Blade ( Single) ABS /Stainless Steel Sterile Device, Single Use Only. Designed to release the transverse carpal ligament.

    Recall: Z-0381-2014 · Initiated October 25, 2013

    Recall

    Recall Number
    Z-0381-2014
    Event Number
    66792
    Firm
    Biomet, Inc.
    FEI Number
    1825034
    Product Code
    FZX
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    October 25, 2013
    Posted
    November 22, 2013
    Terminated
    May 6, 2015
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989

    Description

    REF 200068 Security (TM) Enclosed Carpal Tunnel System Blade ( Single) ABS /Stainless Steel Sterile Device, Single Use Only. Designed to release the transverse carpal ligament.

    Reason

    Security Blades were manufactured oversized and potentially won't advance or may be difficult to advance through the mating Security Clip.

    Action

    10/25/2013 Urgent Medical Device Recall Notifications were sent to each Distributor and Risk/Recall Manager at each direct account identifying the recalled device, possible adverse health consequences and instructing consignees to immediately locate and remove devices from circulation, following instructions on the FAX back form and returning it within 3 business days to FAX 574-372-1683 and returning product to Biomet Return Goods, 56 East Bell Drive Warsaw In 46580. Questions should be directed to 574-372-1570 M-F, 8 a.m. to 5 p.m.

    Distribution

    Worldwide Distribution: USA (nationwide) and Internationally to Japan.

    Quantity

    1130