BEUDAMED
    FDA Recall Terminated

    Vu a-POD Intervertebral Body Fusion Device. Packaged as surgical kits containing all implants and instruments required for a procedure. Also packaged as individual instruments and implants in poly bags distributed as replenishment for surgical kits. Theken Spine, LLC, Akron, OH 44306. Indicated for use as an adjunct for fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1.

    Recall: Z-1475-2011 · Initiated October 19, 2010

    Recall

    Recall Number
    Z-1475-2011
    Event Number
    57100
    Firm
    Integra LifeSciences Corp.
    FEI Number
    3003418325
    Product Code
    MQP
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    October 19, 2010
    Posted
    March 2, 2011
    Terminated
    September 19, 2012
    Address
    311 Enterprise Dr, Plainsboro, NJ, 08536-3344

    Description

    Vu a-POD Intervertebral Body Fusion Device. Packaged as surgical kits containing all implants and instruments required for a procedure. Also packaged as individual instruments and implants in poly bags distributed as replenishment for surgical kits. Theken Spine, LLC, Akron, OH 44306. Indicated for use as an adjunct for fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1.

    Reason

    The IFU provided with the device contains incorrect information in the Indications for Use Section, stating the following: The Theken Spine Vu a"POD Intervertebral Body Fusion Device is intended for use as a stand alone implant when used with the SpinPlate provided in the set.

    Action

    On 10/19/2010 the firm sent "URGENT : FIELD CORRECTION ACTION Letters to their customers. The letters identified the affected product and explained the reason for the recall. The letter also stated that the issue is not believed to have a health impact on patients. Physicians are asked to continue to exercise their clinical judgment with any periodic patient follow up. Attached to the letters were IFUs containing the correct information. Customers are to complete and return the enclosed Recall Acknowledgement Form per the instructions provided. Questions can be directed to Suzanne B. Wojcik, Sr. Dir Regulatory Affairs and Quality Assurance, at 330-835-8528.

    Distribution

    Nationwide Distribution -- AL, AZ, CA, CT, ID, KS, MO, NH, NV, NY, OH, OK, TX & UT.

    Quantity

    2,163 pieces