Z-0944-2018Class II

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

Name: Z-0944-2018 ReWalk Personal 6.0. Catalog number: 50-20-0004
Creator: Argo Medical Technologies Ltd
Published: 2017-08-14
License: https://open.fda.gov/license/

Lifeward, Inc. / initiated 2017-08-14 / Terminated

FDA source

Argo Medical Technologies Ltd began a recall of ReWalk Personal 6.0. Catalog number: 50-20-0004 on 2017-08-14. FDA classified it as Class II and gives the reason as "Firm received complaints for ReWalk Personal 6.0 of an injury to tibia and fibula". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0944-2018
Classification: Class II
Status: Terminated
Initiated: 2017-08-14
Posted: 2018-03-09
Terminated: 2019-11-12
Recalling firm: Lifeward, Inc.
Product: ReWalk Personal 6.0. Catalog number: 50-20-0004.
Product code: PHL Powered Exoskeleton
Reason for recall: Firm received complaints for ReWalk Personal 6.0 of an injury to tibia and fibula.
FDA root cause: Other
Action: Customers were notified via letter on 08/14/2017.
Quantity in commerce: 127
Distribution: US and foreign.
Product codes and lots: Date range of Distribution: 09/01/2015 to 09/06/2017.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0944-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0944-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-09

Product code PHL

K160987Class IIReWalk(TM)Rewalk Robotics, Inc. / cleared 2016-07-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)