BEUDAMED
    FDA Enforcement Class II Terminated

    BiMobile UHMWPE Liner: ID-28mm/OD-54mm, Reference Number 184-260/04 The LINK BiMobile Dual Mobility System is indicated for patients with mobility-limiting diseases, fractures or defects which cannot be treated by conservative or osteosynthetic procedures. The device is intended for cemented and cementless use.

    Recall: Z-0729-2019 · Reported January 23, 2019

    Enforcement

    Recall Number
    Z-0729-2019
    Event ID
    81762
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Waldemar Link GmbH & Co. KG (Mfg Site)
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 23, 2019
    Initiation Date
    December 4, 2018
    Classification Date
    January 11, 2019
    Termination Date
    June 5, 2020
    Address
    Oststr. 4-10, Norderstedt, N/A, Germany

    Description

    BiMobile UHMWPE Liner: ID-28mm/OD-54mm, Reference Number 184-260/04 The LINK BiMobile Dual Mobility System is indicated for patients with mobility-limiting diseases, fractures or defects which cannot be treated by conservative or osteosynthetic procedures. The device is intended for cemented and cementless use.

    Reason

    The internal labeling included with these implants may include incorrect part numbers and could result in these incorrect labels being added to patient records.

    Code Info

    Lot# 1707116

    Distribution

    US distribution to states of: AZ, FL, GA, LA, MI, MN, TX, and WA.

    Quantity

    31