BEUDAMED
    FDA Recall Terminated

    ORTHOFIX Firebird Spinal Fixation System, Pedicle Screw Spinal System, Reduction Case, Part #68-0111, Lot #16518-LC18. Intended for use in conjunction with Multi-Axial Reduction Screw Assemblies. During assembly of a construct, the Anti-Splay Cap locks onto the Screw Body to prevent the Screw Body tabs from splaying (spreading apart). The Anti-Splay Cap is subsequently removed from the Screw Body after assembly of the construct. The Anti-Splay Cap is a stainless steel machined instrument. The instrument is used within the Firebird Reduction Kit (Domestic, 44-9050) and the ICON Reduction Kit (International, 68-0010). Product Code: NKB-Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease. Class II.

    Recall: Z-1608-2011 · Initiated October 22, 2010

    Recall

    Recall Number
    Z-1608-2011
    Event Number
    57211
    Firm
    Orthofix Inc
    FEI Number
    2183449
    Product Code
    NKB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 22, 2010
    Posted
    March 8, 2011
    Terminated
    April 25, 2011
    Address
    3451 Plano Parkway, Lewisville, TX, 75056-9453

    Description

    ORTHOFIX Firebird Spinal Fixation System, Pedicle Screw Spinal System, Reduction Case, Part #68-0111, Lot #16518-LC18. Intended for use in conjunction with Multi-Axial Reduction Screw Assemblies. During assembly of a construct, the Anti-Splay Cap locks onto the Screw Body to prevent the Screw Body tabs from splaying (spreading apart). The Anti-Splay Cap is subsequently removed from the Screw Body after assembly of the construct. The Anti-Splay Cap is a stainless steel machined instrument. The instrument is used within the Firebird Reduction Kit (Domestic, 44-9050) and the ICON Reduction Kit (International, 68-0010). Product Code: NKB-Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease. Class II.

    Reason

    There is a possibility that certain Anti-Splay Caps may not mate properly during assembly of the construct to the Screw Body with Multi-Axial Reduction Screw Assemblies.

    Action

    The firm, Orthofix, sent an "URGENT: PRODUCT RECALL" letter dated October 22, 2010 to all customers. The letter describes the product, problem and the action to be taken by the customers. The customers were instructed to: 1) identify and remove the affected product 2) complete the enclosed Tracking and Verification Form via fax to: Orthofix Inc. at 214-937-2764, and 3) contact their Account Services Representative at 1-888-298-5700 and obtain a return authorization number to return product to Orthofix, Inc. The letter also states that Orthofix Inc., will provide replacement Anti-Splay Caps via priority delivery. If you have any questions regarding the removal and return of this product to Orthofix Inc., please contact your Account Service Representative at 1-888-298-5700. Should you have any other questions or concerns, please contact the Director of Regulatory Affairs at 214-937-2061 or by email: [email protected].

    Distribution

    Nationwide distribution: USA including states of: CA, CO, FL, LA , MD, MI, MO, NJ, NY, OH, TN, VA, and WA.

    Quantity

    166 Units