BEUDAMED
    FDA Recall Terminated

    Blackstone Medical: ICON Modular Pedicle Screw System; P/N's 54-9011 (implant set), 54-9020 (instrument case# I), 54-9030 (instrument case #2), spinal implants.

    Recall: Z-1655-2009 · Initiated May 21, 2009

    Recall

    Recall Number
    Z-1655-2009
    Event Number
    52051
    Firm
    Blackstone Medical, Inc.
    FEI Number
    3001238051
    Product Code
    MNI
    Status
    Terminated
    Root Cause
    Finished device change control
    Initiated
    May 21, 2009
    Posted
    July 6, 2009
    Terminated
    April 7, 2015
    Address
    1211 Hamburg Tpke, Suite 300, Wayne, NJ, 07470

    Description

    Blackstone Medical: ICON Modular Pedicle Screw System; P/N's 54-9011 (implant set), 54-9020 (instrument case# I), 54-9030 (instrument case #2), spinal implants.

    Reason

    Product marketed without an approved 510(k)

    Action

    Blackstone issued the recall notice to distributors by FedEx and email on May 21, 2009. This notification provides instructions to the field representatives how to return the product to Blackstone Medical. The Dear Doctor (Surgeon) letters are being sent Tues, May 26, 2009.

    Distribution

    Nationwide

    Quantity

    63 implant kits, 80 instrument kits