BEUDAMED
    FDA Recall Terminated

    6.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI

    Recall: Z-0355-2013 · Initiated January 5, 2009

    Recall

    Recall Number
    Z-0355-2013
    Event Number
    52634
    Firm
    NuVasive Inc
    FEI Number
    3002980729
    Product Code
    NKB
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    January 5, 2009
    Posted
    November 19, 2012
    Terminated
    November 19, 2012
    Address
    7475 Lusk Blvd, San Diego, CA, 92121-5707

    Description

    6.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI

    Reason

    The tulip portion of the screw assembly can disengage from the shank after implantation.

    Action

    Telephone communications to the sales representatives of surgeons actively using the Posted Pedicle Screw System were made on 01/05/2009. The calls were unscripted and requested that all inventory be forwarded to NuVasive's San Diego office for quarantine. Surgeons who were actively using the system were also contacted and notified of the situation. Follow-up communications were sent via mail on 01/19/2009 to all surgeons who participated in the Alpha release. The letter informed the customers of the problems identified. Customers were instructed that the recalling firm does not believe any further action is required and they were instructed to monitor the progress of their patients and notify NuVasive if any issues are detected. Customers with questions or concerns are instructed to contact the firm at (858) 909-1964.

    Distribution

    Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC.

    Quantity

    240 units total