Recall Z-0944-2018— Argo Medical Technologies Ltd

Name: FDA recall Z-0944-2018
Creator: U.S. Food and Drug Administration
Published: 2017-08-14

Class II · Terminated

Class II FDA medical device recall by Argo Medical Technologies Ltd, initiated 2017-08-14, terminated 2019-11-12. It names one FDA 510(k) clearance: K160987. Product: 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..

Recalling firm: Argo Medical Technologies Ltd
Classification: Class II
Status: Terminated
Initiated: 2017-08-14
Terminated: 2019-11-12
Firm location: Haifahaifa, Israel

510(k) clearances named in this recall

1 on FDA's record

K160987 — ReWalk(TM)Rewalk Robotics, Inc.·cleared 2016-07-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.