BEUDAMED
    FDA Recall Terminated

    OSTEOMED SPINE Facet Fixation System PrimaLOK FF Threaded Implant Driver Shaft OsteoMed L.P. 3885 Arapaho Road, Addison, Texas 75001

    Recall: Z-0008-2012 · Initiated June 7, 2011

    Recall

    Recall Number
    Z-0008-2012
    Event Number
    59213
    Firm
    Osteomed, Lp 3885 Arapaho Rd Addison TX 75001
    FEI Number
    2027754
    Product Code
    MRW
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    June 7, 2011
    Posted
    October 4, 2011
    Terminated
    December 4, 2012

    Description

    OSTEOMED SPINE Facet Fixation System PrimaLOK FF Threaded Implant Driver Shaft OsteoMed L.P. 3885 Arapaho Road, Addison, Texas 75001

    Reason

    Two of the Implant Driver Assembly tips were reported to break during surgery.

    Action

    OsteoMed LP sent an Urgent --Product Recall letter dated June 7, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory immediately for affected inventory and promptly return any affected inventory to: OsteoMed LP Attan: Rebecca Ellis 3885 Arapaho Road Addison, Texas 75001 If the customer further distributed any of the affected product customers were instructed to immediately contact their accounts and advise them of the recall situation and have them return any devices they may have to OsteoMed at the above address. Customers were asked to complete and return the enclosed response immediately in the enclosed, postage paid envelope even if they do not have the device. For any questions please call (800) 456-7779.

    Distribution

    Nationwide Distribution including PA, TX, CA, IL IA, FL, CT, and MO

    Quantity

    20 units