BEUDAMED
    FDA Recall Terminated

    AutoTac Delivery Handle, REF 400-200, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244. Dental.

    Recall: Z-0561-2013 · Initiated November 19, 2012

    Recall

    Recall Number
    Z-0561-2013
    Event Number
    63744
    Firm
    BioHorizons Implant Systems Inc
    FEI Number
    1000592496
    Product Code
    DZE
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    November 19, 2012
    Posted
    December 19, 2012
    Terminated
    September 24, 2013
    Address
    2300 Riverchase Ctr, Birmingham, AL, 35244-2808

    Description

    AutoTac Delivery Handle, REF 400-200, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244. Dental.

    Reason

    The cleaning instructions provided may not be sufficient to remove residual contaminants after surgical use.

    Action

    BioHorizons sent an "URGENT DEVICE CORRECTION" letter on November 19, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers should contact the Customer Care Department at (888) 246-8338 for questions regarding this recall.

    Distribution

    Worldwide Distribution-USA (nationwide) and the countries of Argentina, Australia, Brazil, Bulgaria, Canada, Cayman Islands, Chile, Colombia, Costa Rica, Ecuador, Egypt, Fiji, France, Germany, Greece, Hong Kong, India, Indonesia, Iran, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Kuwait, Lebanon, Lithuania, Malaysia, Mexico, Panama, Peru, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Spain, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, and Vietnam.

    Quantity

    174 units