BEUDAMED
    FDA Recall 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 · Initiated November 16, 2017

    Recall

    Recall Number
    Z-0320-2018
    Event Number
    78715
    Firm
    Brainlab AG Olof-Palme-Strasse 9 Munich Germany
    FEI Number
    3002619595
    Product Code
    HAW
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    November 16, 2017
    Terminated
    August 24, 2020

    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.

    Action

    Customers were notified, via email on approximately 11/16/2017. Instructions included to identify all affected devices on hand, cease use of the affected device, and a Brainlab Customer Support Representative will contact the customer to arrange a service visit to replace the item

    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