BEUDAMED
    FDA Recall Terminated

    Allofix Insertion Kit, 2.0 mm, Single Drill, Product Usage: MTF Surgical Instruments are designed for the specific needs of the orthopedic surgeon and are intended to be used in conjunction with the associated allograft. This kit is for single use only.

    Recall: Z-2075-2015 · Initiated May 27, 2015

    Recall

    Recall Number
    Z-2075-2015
    Event Number
    71559
    Firm
    Musculoskeletal Transplant Foundation, Inc.
    FEI Number
    3001236616
    Product Code
    HXY
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    May 27, 2015
    Posted
    July 15, 2015
    Terminated
    May 8, 2017
    Address
    125 May St, Ste 300, Edison, NJ, 08837-3264

    Description

    Allofix Insertion Kit, 2.0 mm, Single Drill, Product Usage: MTF Surgical Instruments are designed for the specific needs of the orthopedic surgeon and are intended to be used in conjunction with the associated allograft. This kit is for single use only.

    Reason

    Musculoskeletal Transplant Foundation is recalling a certain lot of Allofix Insertion Kits because they are labeled as having a 2.0mm diameter drill however it may contain a 2.4 mm diameter drill.

    Action

    Musculoskeletal Transplant Foundation notified their affected customers of this recall by sending them a Voluntary Recall Notification Letter dated May 27, 2015 or via telephone. The letter identified the affected product, problem and actions to be taken. For questions contact Customer Service at 1-800-433-6576.

    Distribution

    US Nationwide Distribution in the states of AZ, CA, CO, FL, IL, MI, MN, NC, NJ, NV, PA, TN, TX, UT, WA and WV.

    Quantity

    117 units