BEUDAMED
    FDA Enforcement Class II Terminated

    M/DN Intramedullary Fixation Distal Drill 3.2 mm Diameter Pilot Tip, Item Number/EDI 47225503332, Sterile. orthopedic surgical instrument.

    Recall: Z-3155-2017 · Reported October 4, 2017

    Enforcement

    Recall Number
    Z-3155-2017
    Event ID
    77417
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    October 4, 2017
    Initiation Date
    May 22, 2017
    Classification Date
    September 22, 2017
    Termination Date
    March 29, 2019
    Address
    1800 W Center St, N/A, Warsaw, IN, 46580-2304, United States

    Description

    M/DN Intramedullary Fixation Distal Drill 3.2 mm Diameter Pilot Tip, Item Number/EDI 47225503332, Sterile. orthopedic surgical instrument.

    Reason

    Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

    Code Info

    Lot Numbers: 63616770, 63616771, 63616772, 63413732, 63413734, 63413737, 63443859, 63443861, 63443836, 63469287, 63469288, 63469289, 63474646, 63474647, 63474648, 63511483, 63529994, 63529995, 63529996 & 63530003

    Distribution

    Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.

    Quantity

    224 units