BEUDAMED
    FDA Recall Terminated

    ICON Modular Spinal Fixation System used with the: ICON Implant Case (containing Pedicle Screws) Item Number 54-1090 ICON Instrument Case 1 Item Number: 54-1091 ICON Instrument Case 2 Item Number: 54-1092

    Recall: Z-0716-06 · Initiated December 23, 2005

    Recall

    Recall Number
    Z-0716-06
    Event Number
    34355
    Firm
    Blackstone Medical Inc.
    FEI Number
    3001238051
    Product Code
    KWQ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    December 23, 2005
    Posted
    April 19, 2006
    Terminated
    April 9, 2013
    Address
    90 Brookdale Drive, Springfield, MA, 01104-3206

    Description

    ICON Modular Spinal Fixation System used with the: ICON Implant Case (containing Pedicle Screws) Item Number 54-1090 ICON Instrument Case 1 Item Number: 54-1091 ICON Instrument Case 2 Item Number: 54-1092

    Reason

    Pedicle Screw may disengage in post op period requiring intervention

    Action

    Blackstone Medical notified Distributors by email on 12/23/05 to quarantine inventory. A letter notifying physicans was issued 12/28/05 via Fed''X. Product is to be returned to Blackstone Medical.

    Distribution

    AL,CA, CO, IL, NH, NM, TX Foreign: BMI , Diessen, Germany

    Quantity

    23 sets