BEUDAMED
    FDA Enforcement Class II Terminated

    Zimmer Patient Helper Bed Frame Adapter Assembly The bed frame adapter assembly is intended to be used by qualified medical professionals to adapt a patient helper to a hospital bed. The patient helper is used to aid and assist the patient's mobility within a hospital bed and during bed ingress and egress.

    Recall: Z-1546-2013 · Reported June 26, 2013

    Enforcement

    Recall Number
    Z-1546-2013
    Event ID
    64424
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 26, 2013
    Initiation Date
    February 14, 2013
    Classification Date
    June 14, 2013
    Termination Date
    May 1, 2014
    Address
    345 E Main St, Warsaw, IN, 46580-2746, United States

    Description

    Zimmer Patient Helper Bed Frame Adapter Assembly The bed frame adapter assembly is intended to be used by qualified medical professionals to adapt a patient helper to a hospital bed. The patient helper is used to aid and assist the patient's mobility within a hospital bed and during bed ingress and egress.

    Reason

    The bed frame adapter assemblies may have a weak weld where the patient helper adapter mounting bars attach to the tube.

    Code Info

    Part number 00-0965-002-01

    Distribution

    Worldwide distribution: USA (nationwide) including states of: AL, AR, AZ, CA, CT, FL, HI, IL, KY, MA, MD, MN, MO, NE, NJ, NY, OH, OK, PA, TN, TX, WA, and WI; and country of Canada.

    Quantity

    344 Units