BEUDAMED
    FDA Recall Terminated

    Tornier Arthro Tunneler. For transossous fixation of tendons to bone in rotator cuff repair. Catalog Number: SMB000101

    Recall: Z-0656-2010 · Initiated December 4, 2009

    Recall

    Recall Number
    Z-0656-2010
    Event Number
    54036
    Firm
    TAG Medical Corp. Kibbutz Gaaton Naharia Israel
    FEI Number
    1000272060
    Product Code
    NBH
    Status
    Terminated
    Root Cause
    Process change control
    Initiated
    December 4, 2009
    Posted
    January 19, 2010
    Terminated
    February 29, 2016

    Description

    Tornier Arthro Tunneler. For transossous fixation of tendons to bone in rotator cuff repair. Catalog Number: SMB000101

    Reason

    Device failed to deploy the distal loop

    Action

    Medicsense, the US Agent notified the sole distributor Tornier Inc., Edina, MN of the recall and requested notification to users requesting to discontinue and return product. Letter to customers dated December 4, 2009.

    Distribution

    Nationwide

    Quantity

    60 UNITS