BEUDAMED
    FDA Recall Terminated

    External Implant RBT, D3 Threadform 4.0 X 10.5mm, REF 40105D3, STERILE R, Rx Only, BioHorizons(R), 2300 Riverchase Center, Birmingham, AL 35244 Usage: dental

    Recall: Z-1058-2014 · Initiated December 10, 2013

    Recall

    Recall Number
    Z-1058-2014
    Event Number
    67090
    Firm
    BioHorizons Implant Systems Inc
    FEI Number
    1000592496
    Product Code
    DZE
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    December 10, 2013
    Posted
    February 20, 2014
    Terminated
    March 28, 2014
    Address
    2300 Riverchase Center, Birmingham, AL, 35244-2808

    Description

    External Implant RBT, D3 Threadform 4.0 X 10.5mm, REF 40105D3, STERILE R, Rx Only, BioHorizons(R), 2300 Riverchase Center, Birmingham, AL 35244 Usage: dental

    Reason

    The body length of the External Implant 40105D3 Lot 1302762 labeled as 10.5mm in length is in fact 12mm in length.

    Action

    The firm, BioHorizons, sent an "Urgent Medical Device Recall" letter dated December 10, 2013 to its Consignees. The letter described the product, problem and actions to be taken. The customers were instructed to return unused affected implants and receive replacements free of charge; complete and return the enclosed Customer Reply Form via fax to (205) 484-2195 or scan to PDF and e-mail to [email protected]; If you have affected implants, upon receipt of your completed Customer Reply Form, you will be contacted by BioHorizons Customer Care and provided a Return Authorization number. In addition, if you have already placed any affected implants without incident, no special patient action needs to be taken. If you have any questions regarding this information, please contact our Customer Care Department at (888) 246-8338, Monday through Friday, 7:30am to 6:00pm Central Time.

    Distribution

    Worldwide distribution: US (nationwide) to states of: LA, CA, NC, IL, PA, and NY; and Internationally to: Seoul, Korea; New Delhi, India; Taipei City, Taiwan; and Madrid, Spain.

    Quantity

    119 units