BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0944-2018 · Initiated August 14, 2017

    Recall

    Recall Number
    Z-0944-2018
    Event Number
    79186
    Firm
    Argo Medical Technologies Ltd Matambuilding 30p.O.Box
    FEI Number
    3007615665
    Product Code
    PHL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 14, 2017
    Terminated
    November 12, 2019
    Address
    15054 Haifahaifa 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.

    Action

    Customers were notified via letter on 08/14/2017.

    Distribution

    US and foreign.

    Quantity

    127