BEUDAMED
    FDA Recall Terminated

    PERPOS PLS SYSTEM, CATALOG NO. 9045-02 A sterile, medical device kit consisting of the components listed in Table 1-1 below. The kit is used by medical professionals to stabilize the spine as an aid to fusion through immobilization of the facet joints. A Surgical Technique brochure is provided in Appendix A and other labeling, including instructions for use, is provided in Appendix B.

    Recall: Z-2719-2011 · Initiated March 23, 2011

    Recall

    Recall Number
    Z-2719-2011
    Event Number
    58465
    Firm
    Interventional Spine Inc
    FEI Number
    3003523239
    Product Code
    HXI
    Status
    Terminated
    Root Cause
    Pending
    Initiated
    March 23, 2011
    Posted
    July 1, 2011
    Terminated
    February 14, 2013
    Address
    13700 Alton Pkwy, Ste 160, Irvine, CA, 92618-1618

    Description

    PERPOS PLS SYSTEM, CATALOG NO. 9045-02 A sterile, medical device kit consisting of the components listed in Table 1-1 below. The kit is used by medical professionals to stabilize the spine as an aid to fusion through immobilization of the facet joints. A Surgical Technique brochure is provided in Appendix A and other labeling, including instructions for use, is provided in Appendix B.

    Reason

    This recall has been initiated due to K-wires with a distal tip diameter that may be greater than specified causing an interference fit with the canulated screw. Removing the K-wire during a procedure may dislocate the implant resulting in the implant loosening or being pulled out or position. Use of this product may result in a delay of the surgical procedure and/or pull-out of the facet screw

    Action

    Interventional Spine sent an RECALL NOTIFICATION letter dated March 23, 2011, to all affected customers. The letter identified the product, the problem, and the action needed to be taken by the customer. The customer was instructed to take the following actions: Immediately examine inventory and quarantine product subject to recall. In addition, if this product was further distributed, please notify the Vice President Quality Assurance at once. Consignee were asked to also complete and return the enclosed response form as soon as possible. Consignee with questions were directed to the Consignees' Regional Director or the Vice President Quality Assurance. For further questions, please call (949) 472-0006

    Distribution

    Nationwide Distribution including the states of to NC, NY, TN & VA

    Quantity

    864 units total for all products