BEUDAMED
    FDA Recall Terminated

    Biomet 3i Narrow Right Angle Square Driver Tip. 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-0267-2016 · Initiated August 10, 2015

    Recall

    Recall Number
    Z-0267-2016
    Event Number
    72368
    Firm
    Biomet 3i, LLC
    FEI Number
    1038806
    Product Code
    NDP
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    August 10, 2015
    Posted
    November 12, 2015
    Terminated
    October 12, 2016
    Address
    4555 Riverside Dr, Palm Beach Gardens, FL, 33410-4200

    Description

    Biomet 3i Narrow Right Angle Square Driver Tip. 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

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

    Action

    Beginning on or about 08/10/2015 customers will be notified in writing via FEDEX and instructed to to check their inventory for the identified product and to return any unused quantiles along with the recall response. Biomet 3i will promptly issue replacement product.

    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

    103 pieces