BEUDAMED
    FDA Recall Terminated

    Alphatec Spine Solanas Titanium Pedicle Screw Part Number 63035-14

    Recall: Z-0503-2010 · Initiated August 5, 2009

    Recall

    Recall Number
    Z-0503-2010
    Event Number
    53144
    Firm
    Alphatec Spine, Inc.
    FEI Number
    2027467
    Product Code
    KWP
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    August 5, 2009
    Posted
    December 14, 2009
    Terminated
    June 7, 2010
    Address
    5818 El Camino Real, Carlsbad, CA, 92008-8816

    Description

    Alphatec Spine Solanas Titanium Pedicle Screw Part Number 63035-14

    Reason

    Alphatec Spine discovered that the affected lots were not manufactured correctly in that the screw body portion of the assembly has only 22.5 degrees of angulation in the east-west plane instead of the designed 38-40 degrees.

    Action

    Alphatec Spine telephoned consignees informing them of the above mentioned Public Reason for Recall on August 5, 2009. They were asked to check their inventory to see where this product is located. If the product had not already been used Alphatec arranged to have Federal Express contact consignee for pick-up of the product(s). They were told to expect to receive the replacement(s) within 2-3 days.

    Distribution

    Nationwide distribution.

    Quantity

    158 units