BEUDAMED
    FDA Enforcement Class II Terminated

    Biomet 3i Narrow Right Angle Large Driver Tip (Hexed). Driver tips are attached to a surgical drilling unit to carry components such as implant mounts, healing abutments and screws for placement and removal. For dental and restorative procedures.

    Recall: Z-0266-2016 · Reported November 18, 2015

    Enforcement

    Recall Number
    Z-0266-2016
    Event ID
    72368
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biomet 3i, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 18, 2015
    Initiation Date
    August 10, 2015
    Classification Date
    November 12, 2015
    Termination Date
    October 12, 2016
    Address
    4555 Riverside Dr, N/A, Palm Beach Gardens, FL, 33410-4200, United States

    Description

    Biomet 3i Narrow Right Angle Large Driver Tip (Hexed). Driver tips are attached to a surgical drilling unit to carry components such as implant mounts, healing abutments and screws for placement and removal. For dental and restorative procedures.

    Reason

    The RASH3N, a hexed, abutment screw driver tip has been labeled and distributed as RASQ3N, a square, abutment screw driver tip. Additionally, the RASQ3N received the RASH3N's laser marking "RASH3N" during manufacturing.

    Code Info

    Model # RASH3N Lot # 1184555

    Distribution

    AK, AZ, CA, CO, CT, FL, GA, IA, ID, IL, KY, LA, MA, MD, MI, MS, NC, NE, NJ, NY, OH, OR, PA, SD, TN, TX, UT, VA, WA, and District of Columbia Argentina, Australia, Belgium, Canada, Colombia, Greece, Hong Kong, Ireland, Italy, South Korea, and Kuwait.

    Quantity

    96 pieces