BEUDAMED
    FDA Recall Terminated

    BLACKSTONE Medical Inc. Firebird Spinal Fixation System 6.5mm x 30mm Bone Screw, Self Tapping, Cannulated. BLACKSTONE Medical Inc. Firebird Spinal Fixation System 6.5mm x 30mm Multi-Axial Screw, Self Tapping, Cannulated. The Multi-Axial Screw is a pedicle screw which is inserted into the pedicle with the use of the Multi-Axial Screw Driver. The component is used within the Firebird Spinal Fixation System. The screw is cannulated and available modular (77-7630, pre-assembled with screw head) or non-modular (77-8630, without screw head). Product Code: NKB-Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease. Class II. Intended for use when implanted over a guide wire for additional accuracy with reference to the pedicle.

    Recall: Z-1674-2011 · Initiated October 22, 2010

    Recall

    Recall Number
    Z-1674-2011
    Event Number
    57199
    Firm
    Orthofix Inc
    FEI Number
    2183449
    Product Code
    NKB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 22, 2010
    Posted
    March 16, 2011
    Terminated
    May 31, 2011
    Address
    3451 Plano Parkway, Lewisville, TX, 75056-9453

    Description

    BLACKSTONE Medical Inc. Firebird Spinal Fixation System 6.5mm x 30mm Bone Screw, Self Tapping, Cannulated. BLACKSTONE Medical Inc. Firebird Spinal Fixation System 6.5mm x 30mm Multi-Axial Screw, Self Tapping, Cannulated. The Multi-Axial Screw is a pedicle screw which is inserted into the pedicle with the use of the Multi-Axial Screw Driver. The component is used within the Firebird Spinal Fixation System. The screw is cannulated and available modular (77-7630, pre-assembled with screw head) or non-modular (77-8630, without screw head). Product Code: NKB-Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease. Class II. Intended for use when implanted over a guide wire for additional accuracy with reference to the pedicle.

    Reason

    There is a possibility that certain Multi-Axial Screws have spherical heads measuring less than the allowable tolerance.

    Action

    Orthofix sent an URGENT: PRODUCT RECALL letter dated October 22, 2010. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to contact their accounts immediately and advise them of the recall situation and have them return any affected inventory. For any questions customers were instructed to contact their Account Services Representative at 1-888-298-5700. For questions regarding this recall call 214-937-2061.

    Distribution

    Nationwide Distribution including AZ, NY, TX, MS, LA, FL, NC, and AR.

    Quantity

    27 (19 of 77-7630) (8 of 77-8630)