BEUDAMED
    FDA Recall Terminated

    Synthes Bone Marrow Aspiration System, Sterile, 11 gauge, 15cm needle (without side holes) Indicated for aspirating bone marrow

    Recall: Z-3273-2011 · Initiated January 26, 2011

    Recall

    Recall Number
    Z-3273-2011
    Event Number
    57865
    Firm
    Synthes USA (HQ), Inc.
    FEI Number
    3005180112
    Product Code
    FMF
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    January 26, 2011
    Posted
    September 21, 2011
    Terminated
    April 16, 2015
    Address
    1302 Wrights Ln E, West Chester, PA, 19380-3417

    Description

    Synthes Bone Marrow Aspiration System, Sterile, 11 gauge, 15cm needle (without side holes) Indicated for aspirating bone marrow

    Reason

    Firm became aware that some systems were released to stock without going through the sterilization process.

    Action

    Synthes (USA) sent an "URGENT MEDICAL DEVICE RECALL" letter dated February 4, 2011 to all affected customers. The letter describes the product, problem, and action to be taken. Affected product removed from inventory will be replaced by Synthes. Contact the Synthes Spine Sale Consultant at 1-800-620-7025 ext.6883 for questions concerning this recall.

    Distribution

    Nationwide Distribution-including the states of AR, CO, FL, GA, ID, LA, MA, MD, MO, MT, NY, NC, OH, SC, SD, TN, TX, and VA.

    Quantity

    96 parts