BEUDAMED
    FDA Recall Terminated

    BioHorizons 0.035 Hex Driver, REF 300-377, BioHorizons Implant Systems, Inc., Birmingham, AL 35243, non-sterile, Rx only, REF 300-377.

    Recall: Z-0692-2007 · Initiated March 12, 2007

    Recall

    Recall Number
    Z-0692-2007
    Event Number
    37687
    Firm
    BioHorizons Implant Systems Inc One Perimeter Park South
    FEI Number
    1000592496
    Product Code
    DZE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 12, 2007
    Posted
    April 13, 2007
    Terminated
    September 4, 2007
    Address
    Suite 230, South Birmingham, AL, 35243

    Description

    BioHorizons 0.035 Hex Driver, REF 300-377, BioHorizons Implant Systems, Inc., Birmingham, AL 35243, non-sterile, Rx only, REF 300-377.

    Reason

    Premature wear; The material from which the hex driver was made was improperly hardened during manufacturing and could lead to premature wear.

    Action

    Letters and replacement drivers were sent to the consignees (both domestic and abroad) on 3/12/2007 explaining the problem and requesting that the consignee discard the instrument and use the replacement. They were delivered via United Parcel Service (UPS) 3rd day package delivery.

    Distribution

    Worldwide Distribution -- USA and countries of Canada, Norway, Australia, Spain, Brazil, Pakistan, Israel, Latvia, Japan, Columbia, Thailand, Turkey, Italy, South Korea, India, Taiwan, Ukraine, Russia, United Arab Emirates, Saudi Arabia, Hong Kong, Romania, UK, Kuwait, and Lithuania

    Quantity

    363 units