BEUDAMED
    FDA Enforcement Class II 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 · Reported December 4, 2013

    Enforcement

    Recall Number
    Z-0381-2014
    Event ID
    66792
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 4, 2013
    Initiation Date
    October 25, 2013
    Classification Date
    November 22, 2013
    Termination Date
    May 6, 2015
    Address
    56 E Bell Dr, N/A, Warsaw, IN, 46582-6989, United States

    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.

    Code Info

    Catalog Number: 200068 Medical Device Listing Number: B008657 Lot Number Identification: 088610, 090600, 143810, 257060, 289900, 365910, 460490, 558300, 626660, 697320,767260,795090,857730,864640,979680

    Distribution

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

    Quantity

    1130