BEUDAMED
    FDA Enforcement Class II Terminated

    Device Brand Name: Distal Radius Fracture Repair System Device Classification Name: Plate, Fixation, Bone Device Common Name: Drill Guide DNP 3.3mm Labeling: DRILL GUIDE DNP 3.3 MM NON-STERILE LOT NB0311 QTY 1 DePuy P.O Box 988 Warsaw IN 46581

    Recall: Z-2212-2014 · Reported August 20, 2014

    Enforcement

    Recall Number
    Z-2212-2014
    Event ID
    68651
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 20, 2014
    Initiation Date
    June 23, 2014
    Classification Date
    August 13, 2014
    Termination Date
    July 14, 2015
    Address
    56 E Bell Dr, N/A, Warsaw, IN, 46582-6989, United States

    Description

    Device Brand Name: Distal Radius Fracture Repair System Device Classification Name: Plate, Fixation, Bone Device Common Name: Drill Guide DNP 3.3mm Labeling: DRILL GUIDE DNP 3.3 MM NON-STERILE LOT NB0311 QTY 1 DePuy P.O Box 988 Warsaw IN 46581

    Reason

    The firm received complaints indicating that the drill guide becomes stuck in the jig. The drill guide can be placed in the jig about halfway before it becomes stuck.

    Code Info

    Catalog Number: DNPDG, Lot Number: NB0311 and NB0611

    Distribution

    The product was distributed domestically and to internationally. Domestically to CA, PA, IA, CO, NY, MD, NC,AL, AZ, IL, GA, VA. Netherlands, Argentina,

    Quantity

    37