BEUDAMED
    FDA Enforcement Class II Terminated

    Telluride Percutaneous Rod Inserter Long, Model #7706-1904. The Inserter is a reusable device provided within an aluminum sterilization case along with other orthopedic manual surgical instruments. The case consists of three trays of instruments, and the middle tray contains a quantity of two Inserters. The Inserter is for use as part of a Telluride System pedicle screw procedure.

    Recall: Z-1089-2015 · Reported February 18, 2015

    Enforcement

    Recall Number
    Z-1089-2015
    Event ID
    70376
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biomet Spine, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 18, 2015
    Initiation Date
    December 19, 2011
    Classification Date
    February 10, 2015
    Termination Date
    March 23, 2015
    Address
    310 Interlocken Pkwy Ste 120, N/A, Broomfield, CO, 80021-3464, United States

    Description

    Telluride Percutaneous Rod Inserter Long, Model #7706-1904. The Inserter is a reusable device provided within an aluminum sterilization case along with other orthopedic manual surgical instruments. The case consists of three trays of instruments, and the middle tray contains a quantity of two Inserters. The Inserter is for use as part of a Telluride System pedicle screw procedure.

    Reason

    The Telluride Percutaneous Rod Inserter Long does not contain a feature that locks the Rod in place during use. There is a potential for the Rod to disengage from the Inserter during insertion, and could lead to harm to the patient.

    Code Info

    LOT Numbers: L561968 and L570545 Product Code: 7703-1600

    Distribution

    Distributed to TX, OH, NE and NY.

    Quantity

    10