BEUDAMED
    FDA Recall Terminated

    Synthes Cannulated Distal Femoral Nail (Trauma Nail), Part Number 450.851S, 420MM-Sterile. Orthppedic implant device.

    Recall: Z-2243-2013 · Initiated April 18, 2013

    Recall

    Recall Number
    Z-2243-2013
    Event Number
    64406
    Firm
    Synthes USA HQ, Inc.
    FEI Number
    3005180112
    Product Code
    HTY
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    April 18, 2013
    Posted
    September 18, 2013
    Terminated
    March 30, 2015
    Address
    1302 Wrights Ln E, West Chester, PA, 19380-3417

    Description

    Synthes Cannulated Distal Femoral Nail (Trauma Nail), Part Number 450.851S, 420MM-Sterile. Orthppedic implant device.

    Reason

    Firm discovered that a nail that was within the scope of a previous Trauma Nail recall had been distributed.

    Action

    A letter dated April 18, 2013 was sent to one consignee who was identified as receiving the affected device. A review of inventory and return of any affected product on hand was requested. Negative responses were also requested.

    Distribution

    US distribution to MA.

    Quantity

    1