BEUDAMED
    FDA Enforcement Class II Terminated

    HipLOC CHS Plate/Lag Screw Introducer

    Recall: Z-0885-2016 · Reported March 2, 2016

    Enforcement

    Recall Number
    Z-0885-2016
    Event ID
    73258
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 2, 2016
    Initiation Date
    February 16, 2016
    Classification Date
    February 25, 2016
    Termination Date
    February 14, 2017
    Address
    56 E Bell Dr, N/A, Warsaw, IN, 46582-6989, United States

    Description

    HipLOC CHS Plate/Lag Screw Introducer

    Reason

    A complaint was received where the Hiploc Plate/Lag Screw Introducer was undersized and would not accept the introducor coupling screw. It appears now that not all parts manufactured to Rev A drawing were reworked.

    Code Info

    Catalog Number: 35-000263; and Lot Number Identification: 1807188, 1807189, 1943563, and 2577847.

    Distribution

    US Distribution to the states of : MO, UT, AZ, IL, PA, KY, MI, NC, NJ, MN and GA., and Internationally to The Netherlands.

    Quantity

    23 units