BEUDAMED
    FDA Recall Terminated

    Accessories for the Captiva Spine SmartLOX Cervical Plate System. Products are labeled in part: "***Part Number CP40012***12mm Drill Bit***Lot Number 89427-2 R***" "***Part Number CP40014***14mm Drill Bit***Lot Number 89427-3-R***" The Captiva Spine SmartLOX Cervical Plate System is intended for the anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion.

    Recall: Z-1648-2012 · Initiated November 22, 2011

    Recall

    Recall Number
    Z-1648-2012
    Event Number
    61811
    Firm
    Captiva Spine, Inc 967 Alternate A1A Suite1
    FEI Number
    3006082533
    Product Code
    KWQ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    November 22, 2011
    Posted
    May 23, 2012
    Terminated
    November 18, 2013
    Address
    Jupiter, FL, 33477

    Description

    Accessories for the Captiva Spine SmartLOX Cervical Plate System. Products are labeled in part: "***Part Number CP40012***12mm Drill Bit***Lot Number 89427-2 R***" "***Part Number CP40014***14mm Drill Bit***Lot Number 89427-3-R***" The Captiva Spine SmartLOX Cervical Plate System is intended for the anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion.

    Reason

    Captiva Spine is recalling the SmartLOX Cervical Plate components 12 & 14 mm Drill Bits, Single Barrel Variable Drill Guides, and Double Barrel Fixed Drill Guides. The components are part of the instrumentation kit used to complete an anterior screw fixation of the cervical spine. There is a potential risk for the drills to not properly fit through the drill guides due to an overlap in the dime

    Action

    Captiva Spine notified customers of the recall by letter on November 23, 2011, and advised that the affected products would be replaced. Customers were asked to return the drill guides and unused drills with the provided return labels. For questions customers should call 877-772-5571. For questions regarding this recall call 561-277-9480.

    Distribution

    Nationwide Distribution including TX, IN, UT, AZ, GA, CA, AL, MI, and MN.

    Quantity

    212 units