BEUDAMED
    FDA Enforcement Class II Terminated

    ReWalk Personal 6.0. Catalog number: 50-20-0004.

    Recall: Z-0944-2018 · Reported March 21, 2018

    Enforcement

    Recall Number
    Z-0944-2018
    Event ID
    79186
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Argo Medical Technologies Ltd
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 21, 2018
    Initiation Date
    August 14, 2017
    Classification Date
    March 9, 2018
    Termination Date
    November 12, 2019
    Address
    Matambuilding 30p.O.Box 15054, Haifahaifa, N/A, Israel

    Description

    ReWalk Personal 6.0. Catalog number: 50-20-0004.

    Reason

    Firm received complaints for ReWalk Personal 6.0 of an injury to tibia and fibula.

    Code Info

    Date range of Distribution: 09/01/2015 to 09/06/2017.

    Distribution

    US and foreign.

    Quantity

    127