Date Initiated by Firm |
August 14, 2017 |
Create Date |
March 09, 2018 |
Recall Status1 |
Terminated 3 on November 12, 2019 |
Recall Number |
Z-0944-2018 |
Recall Event ID |
79186 |
510(K)Number |
K160987 K131798
|
Product Classification |
Powered Exoskeleton - Product Code PHL
|
Product |
ReWalk Personal 6.0. Catalog number: 50-20-0004. |
Code Information |
Date range of Distribution: 09/01/2015 to 09/06/2017. |
Recalling Firm/ Manufacturer |
Argo Medical Technologies Ltd Matambuilding 30p.O.Box 15054 Haifahaifa Israel
|
Manufacturer Reason for Recall |
Firm received complaints for ReWalk Personal 6.0 of an injury to tibia and fibula.
|
FDA Determined Cause 2 |
Other |
Action |
Customers were notified via letter on 08/14/2017. |
Quantity in Commerce |
127 |
Distribution |
US and foreign. |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = PHL and Original Applicant = REWALK ROBOTICS INC.
|