BEUDAMED
    FDA Recall Terminated

    Medtronic Midas Rex Legend tapered dissecting tool, Model F2/8TA23 Medtronic Powered Surgical Solutions, Forth Worth, TX Intended for use in Spinal, Cranial, Orthopedic, General Surgical and Plastic Surgery applications for transection, osteotomy, graft harvesting, bone shaping, laminectomy, entry hole, suture hole, and midface advancement.

    Recall: Z-2156-2008 · Initiated May 30, 2008

    Recall

    Recall Number
    Z-2156-2008
    Event Number
    48472
    Firm
    Medtronic Powered Surgical Solutions
    FEI Number
    1625507
    Product Code
    HBB
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    May 30, 2008
    Posted
    August 23, 2008
    Terminated
    August 22, 2009
    Address
    4620 N Beach St, Fort Worth, TX, 76137-3219

    Description

    Medtronic Midas Rex Legend tapered dissecting tool, Model F2/8TA23 Medtronic Powered Surgical Solutions, Forth Worth, TX Intended for use in Spinal, Cranial, Orthopedic, General Surgical and Plastic Surgery applications for transection, osteotomy, graft harvesting, bone shaping, laminectomy, entry hole, suture hole, and midface advancement.

    Reason

    Cutting flute geometry of surgical dissecting tools may be outside of established tolerance. This may lead to reduced cutting performance, inability to perform desired dissection, increased risk of overheating, and potential need for revision surgery.

    Action

    Firm notified consignees by Urgent: Medical Device Recall letter sent May 30, 2008. The letter requires consignees to immediately compare their inventory of products against the list provided and quarantine any unused dissecting tools. The letter also states that Medtronic would provide replacement product to match the quantity and type returned by the consignees' institution.

    Distribution

    Nationwide Distribution.

    Quantity

    1,306 units