BEUDAMED
    FDA Enforcement Class II Terminated

    Active Articulation E1. Intended for use with either primary or revision hip arthroplasty.

    Recall: Z-1465-2013 · Reported June 12, 2013

    Enforcement

    Recall Number
    Z-1465-2013
    Event ID
    65209
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 12, 2013
    Initiation Date
    April 26, 2013
    Classification Date
    June 5, 2013
    Termination Date
    August 29, 2013
    Address
    56 E Bell Dr, N/A, Warsaw, IN, 46582-6989, United States

    Description

    Active Articulation E1. Intended for use with either primary or revision hip arthroplasty.

    Reason

    Biomet is recalling Active Articulation E1 Hip Bearing implants. Biomet has initiated this action following an investigation which identified that outer label indicates two conflicting O.D. sizes while the inner labels indicate an incorrect O.D. size. The implant itself is etched with the correct O.D. size.

    Code Info

    Part numbers: EP-200162, EP-200162, EP-200164, and EP-200166 with Lot numbers: 027050, 101470, 115950, 101480, 247990, 948810, 967270, 027070, 287820, 729870, and 860880.

    Distribution

    Distributed in New York.

    Quantity

    8 units