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U.S. Department of Health and Human Services

Class 2 Device Recall ReWalk Personal 6.0.

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 Class 2 Device Recall ReWalk Personal 6.0.see related information
Date Initiated by FirmAugust 14, 2017
Create DateMarch 09, 2018
Recall Status1 Terminated 3 on November 12, 2019
Recall NumberZ-0944-2018
Recall Event ID 79186
510(K)NumberK160987 
Product Classification Powered Exoskeleton - Product Code PHL
ProductReWalk Personal 6.0. Catalog number: 50-20-0004.
Code Information Date range of Distribution: 09/01/2015 to 09/06/2017.
FEI Number 3007615665
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
ActionCustomers were notified via letter on 08/14/2017.
Quantity in Commerce127
DistributionUS and foreign.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = PHL
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