BEUDAMED
    FDA Enforcement Class II Terminated

    A.L.P.S. - Medium Bone Plate Forceps. Orthopedic manual surgical instrument.

    Recall: Z-2072-2015 · Reported July 22, 2015

    Enforcement

    Recall Number
    Z-2072-2015
    Event ID
    71549
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 22, 2015
    Initiation Date
    June 17, 2015
    Classification Date
    July 14, 2015
    Termination Date
    March 22, 2016
    Address
    56 E Bell Dr, N/A, Warsaw, IN, 46582-6989, United States

    Description

    A.L.P.S. - Medium Bone Plate Forceps. Orthopedic manual surgical instrument.

    Reason

    Medium Bone Plate Forceps was assembled with the incorrect grip arm tip. Potential that the surgeon will be unable to provisionally clamp the plate to the patient's bone.

    Code Info

    Part Number: 816301006 Lot Numbers: 099216, 093776, 093717, 093716, 088526, 081179, 072525, 072524

    Distribution

    Domestic: TX NJ, NC, KY, MA, SD, MO, AL, IN, GA, AR International: Netherlands, Japan, Costa Rica

    Quantity

    223