BEUDAMED
    FDA Enforcement Class II Terminated

    PerFuse Decompression Instrument PN: 800-0541, Lot:100650. Designed to access the femoral head for decompression.

    Recall: Z-1814-2016 · Reported June 1, 2016

    Enforcement

    Recall Number
    Z-1814-2016
    Event ID
    74025
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 1, 2016
    Initiation Date
    April 11, 2016
    Classification Date
    May 25, 2016
    Termination Date
    May 30, 2017
    Address
    56 E Bell Dr, N/A, Warsaw, IN, 46582-6989, United States

    Description

    PerFuse Decompression Instrument PN: 800-0541, Lot:100650. Designed to access the femoral head for decompression.

    Reason

    The Trocar and Plunger Assemblies are missing from the instrument, which could result in a delay in surgery greater than 30 minutes.

    Code Info

    PerFuse Decompression Instrument PN: 800-0541, Lot:100650

    Distribution

    Distributed in the US states of CA, GA, MN, and OH, and in the Netherlands.

    Quantity

    22