BEUDAMED
    FDA Enforcement Class II Terminated

    RBT, Internal Implant, Laser-Lok, 5.0 x 15mm, 5.7 Platform, REF LPBR5015, Rx only, Sterile R, BIOHORIZONS(R), Dental Implant

    Recall: Z-0391-2016 · Reported December 16, 2015

    Enforcement

    Recall Number
    Z-0391-2016
    Event ID
    72598
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    BioHorizons Implant Systems Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 16, 2015
    Initiation Date
    October 30, 2015
    Classification Date
    December 7, 2015
    Termination Date
    February 4, 2016
    Address
    2300 Riverchase Ctr, N/A, Hoover, AL, 35244-2808, United States

    Description

    RBT, Internal Implant, Laser-Lok, 5.0 x 15mm, 5.7 Platform, REF LPBR5015, Rx only, Sterile R, BIOHORIZONS(R), Dental Implant

    Reason

    An incorrect label reading 10.5mm and not the specified 15mm was placed on the implant inner vial packaging.

    Code Info

    Lot 1404442

    Distribution

    Worldwide Distribution - US including CA, CO, NY, OH, WA, AZ MI, MD, GA, NC, and Internationally to Iran.

    Quantity

    32 units