BEUDAMED
    FDA Enforcement Class II Terminated

    Ringloc+ Acetabular Shell Finned 52 mm, PN 16-104152, hip prosthesis component.

    Recall: Z-1123-2015 · Reported February 25, 2015

    Enforcement

    Recall Number
    Z-1123-2015
    Event ID
    70438
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 25, 2015
    Initiation Date
    January 9, 2015
    Classification Date
    February 17, 2015
    Termination Date
    October 22, 2015
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989, United States

    Description

    Ringloc+ Acetabular Shell Finned 52 mm, PN 16-104152, hip prosthesis component.

    Reason

    Biomet recalled the Mallory Head 4 Finned Acetabular Shell 50mm (Lot 364600) and Ringloc + Acetabular Shell Limited Hole Finned 52 mm (Lot 427840) following a mix up in packaging with the two.

    Code Info

    Catalog Number: 16-104152 Lot Number Identification: 427840

    Distribution

    Distributed in the states of VA and TX and the country of Japan.

    Quantity

    17