BEUDAMED
    FDA Recall Terminated

    BioHorizons Maximus 3.0 surgical kit, also marketed as BioHorizons One-piece 3.0 Implants and Surgical Kit

    Recall: Z-0252-2007 · Initiated December 28, 2005

    Recall

    Recall Number
    Z-0252-2007
    Event Number
    36764
    Firm
    BioHorizons Implant Systems Inc One Perimeter Park South
    FEI Number
    1000592496
    Product Code
    DZE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 28, 2005
    Posted
    December 6, 2006
    Terminated
    August 11, 2007
    Address
    Suite 230, South Birmingham, AL, 35243

    Description

    BioHorizons Maximus 3.0 surgical kit, also marketed as BioHorizons One-piece 3.0 Implants and Surgical Kit

    Reason

    Dental implants were distributed which lacked the proper instruments for implantation.

    Action

    The firm initiated a recall on December 28, 2005 via US Mail. The letter explains the new implants introduced and explains the need for two additional instruments, the Handpiece and Ratchet Adapter, which are necessary to implant the new one-piece, ball-top 3.0mm diameter implant. A second letter was sent to all non-responding consignees on October 20, 2006 stating the same. The distributors were notified by electronic mail on 11/01/2006.

    Distribution

    Worldwide, including USA, Australia, Brazil, Canada, Chile, Colombia, Egypt, El Salvador, India, Israel, Italy, Ireland, Germany, Japan, Kuwait, Latvia, Lithuania, Mexico, Romania, Russia, Singapore, South Africa, Taiwan, United Arab Emirates, and United Kingdom.

    Quantity

    470 units