BEUDAMED
    FDA Enforcement Class II Terminated

    Cortical Pin 2.0 mm,Sterile, FREEZE DRIED: Store at ambient temperature. Do Not freeze.

    Recall: Z-2210-2015 · Reported August 5, 2015

    Enforcement

    Recall Number
    Z-2210-2015
    Event ID
    71564
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Musculoskeletal Transplant Foundation, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    August 5, 2015
    Initiation Date
    May 27, 2015
    Classification Date
    July 24, 2015
    Termination Date
    December 17, 2015
    Address
    125 May St Ste 300, N/A, Edison, NJ, 08837-3264, United States

    Description

    Cortical Pin 2.0 mm,Sterile, FREEZE DRIED: Store at ambient temperature. Do Not freeze.

    Reason

    Musculoskeletal Transplant Foundation (MTF) is recalling one lot of MTF's Allograft Cortical Pins because the lot was labeled as a 2.0 mm diameter pin and it may contain a 2.4 mm diameter pin.

    Code Info

    Lot #06512078901017, Item #400920. The tissue is placed in a retainer and sealed in a blister pack

    Distribution

    Distributed in the states of AZ, CO, MI, MN, NC, OH and TX.

    Quantity

    22 units