BEUDAMED
    FDA Recall Terminated

    Indus Invue Screw Caddy, Model: SI70097 The caddy holds, in an organized fashion within the case, a variety of shapes and sizes of plates and screws used during fixation of anterior cervical plates to provide stabilization during the development of spine fusions. There is an array of 108 holes that store 3 types of screws. O4.2mm Self-Drilling, O4.2mm Self-Tapping, and O4.5mm Self-Tapping screws which are separated by type and screw length. The caddy has features to hold the screws in place. Recall expanded on 8/21/2013 to include additional lots of this product.

    Recall: Z-1933-2013 · Initiated June 21, 2013

    Recall

    Recall Number
    Z-1933-2013
    Event Number
    65653
    Firm
    SpineFrontier, Inc.
    FEI Number
    3005977257
    Product Code
    FSM
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    June 21, 2013
    Posted
    August 8, 2013
    Terminated
    January 11, 2016
    Address
    500 Cummings Ctr, Ste 3500, Beverly, MA, 01915-6516

    Description

    Indus Invue Screw Caddy, Model: SI70097 The caddy holds, in an organized fashion within the case, a variety of shapes and sizes of plates and screws used during fixation of anterior cervical plates to provide stabilization during the development of spine fusions. There is an array of 108 holes that store 3 types of screws. O4.2mm Self-Drilling, O4.2mm Self-Tapping, and O4.5mm Self-Tapping screws which are separated by type and screw length. The caddy has features to hold the screws in place. Recall expanded on 8/21/2013 to include additional lots of this product.

    Reason

    Difficulty removing screws from the Invue caddies.

    Action

    SpineFrontier sent a Urgent Invue Caddy Advisory letter dated July 10, 2013, to all affected customers. Customers were advised the removal of the Invue Screw Caddy, SI70097 from the field for modification. Customers were asked to return the parts to SpineFrontier and to complete an Acknowledgement Form indicating that they have read the notice and will initiate the immediate return of the parts noted above. Please feel free to contact us at (978) 232-3990. On 8/21/2013 the recall was expanded.

    Distribution

    Worldwide Distribution - USA, including the states of CT, VA, MA, FL, TX, CO and MS. and the country of Jamaica.

    Quantity

    13