BEUDAMED
    FDA Enforcement Class II 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 · Reported February 26, 2014

    Enforcement

    Recall Number
    Z-1058-2014
    Event ID
    67090
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    BioHorizons Implant Systems Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 26, 2014
    Initiation Date
    December 10, 2013
    Classification Date
    February 20, 2014
    Termination Date
    March 28, 2014
    Address
    2300 Riverchase Center, Birmingham, AL, 35244-2808, United States

    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.

    Code Info

    Lot Number 1302762, Exp 31 MAY 2018

    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