BEUDAMED
    FDA Enforcement Class II Terminated

    DRILL BIT MINI QUICK CONNECT 1.0MM, REF 2312-20-200 & 2312-20-202, NON STERILE

    Recall: Z-0516-2018 · Reported February 14, 2018

    Enforcement

    Recall Number
    Z-0516-2018
    Event ID
    77594
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 14, 2018
    Initiation Date
    June 12, 2017
    Classification Date
    February 4, 2018
    Termination Date
    June 29, 2018
    Address
    56 E Bell Dr, N/A, Warsaw, IN, 46582-6989, United States

    Description

    DRILL BIT MINI QUICK CONNECT 1.0MM, REF 2312-20-200 & 2312-20-202, NON STERILE

    Reason

    A raw material anomaly was discovered in four lots of raw material and has the potential to be on or below the surface of the device components which can increase the risk of instrument fracture

    Code Info

    231220200 Item Number with the following Lot numbers 45785,46151, 47467, 48461, 48809, 100016 & 102325 231220202 Item Number with the following Lot Numbers: 45790, 48477, 48811, 100017, 101028 & 102338

    Distribution

    AK, AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA MD, MI, MN, MO, MT, NC, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA & WV. Internationally to: Australia, Chile, Cost Rica, Ecuador, Netherlands, Panama & Switzerland

    Quantity

    1,524 units