BEUDAMED
    FDA Recall 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 · Initiated June 23, 2014

    Recall

    Recall Number
    Z-2212-2014
    Event Number
    68651
    Firm
    Biomet, Inc.
    FEI Number
    1825034
    Product Code
    HRS
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    June 23, 2014
    Posted
    August 13, 2014
    Terminated
    July 14, 2015
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989

    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.

    Action

    On June 23, 2014 Biomet issued recall notification to their consignees via letter. Notification included affected product issue and instructions for return were provided. Distributors who had affected hospitals in their regions were notified and provided with a copy of the notice that was sent to the hospital. Consignees are being contacted on an individual basis in an attempt to reconcile the product 100%. A response form was provided to all consignees in order for Biomet to track returns. Non-responders will be contacted on an individual basis.

    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