BEUDAMED
    FDA Enforcement Class II Terminated

    Brainlab Navigation System Spine & Trauma 3D with component Brainlab DrapeLink Registration Kit for C-arm Zeihm Vision RFD: Adapter Left

    Recall: Z-0320-2018 · Reported January 17, 2018

    Enforcement

    Recall Number
    Z-0320-2018
    Event ID
    78715
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Brainlab AG
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 17, 2018
    Initiation Date
    November 16, 2017
    Classification Date
    January 5, 2018
    Termination Date
    August 24, 2020
    Address
    Olof-Palme-Strasse 9, N/A, Munich, N/A, N/A, Germany

    Description

    Brainlab Navigation System Spine & Trauma 3D with component Brainlab DrapeLink Registration Kit for C-arm Zeihm Vision RFD: Adapter Left

    Reason

    Due to a human error at a supplier, an unknown number of devices within one specific production lot of Brainlab DrapeLink Adapters (Left/Right) were not manufactured according to defined specifications.

    Code Info

    Model No. 19154, UDI GTIN 04056481132187. Model No. 19154-04, UDI No. GTIN 04056481113926. Serial No. range 7459316001 - 7459316027 and 7714816001 - 7714816017.

    Distribution

    Distributed in the US to Kansas. Distributed internationally to Australia, Finland, France, Germany, Hong Kong, Ireland, Japan, Netherlands, Norway, Sweden, Switzerland, Taiwan, Turkey, United Kingdom.

    Quantity

    80 devices total