ReWalk (now Lifeward) recalls Personal 6.0 exoskeleton after tibia and fibula injury complaints
[RECALL]Aug 14, 2017 · Lifeward · ReWalk Personal 6.0 · Marlborough
Failure Mode
RECALL
Event Date
Aug 14, 2017
Primary Entity
Lifeward
Robotic Platform
ReWalk Personal 6.0
Jurisdiction / Location
Marlborough
Audit Standard
Physical State Verified
Incident Abstract & Audit Findings
ReWalk Robotics received complaints of tibia and fibula injury associated with use of the ReWalk Personal 6.0 powered exoskeleton (distributed Sept 2015 to Sept 2017). ReWalk rebranded to Lifeward in 2024. Source: FDA Class 2 device recall Z-0944-2018 (127 units; device K160987), accessdata.fda.gov.
System & Fleet Architecture
Operating Manufacturer
Hardware Platform
Operational Sectors
Primary Sources & Evidentiary Filings
- Inspect Filing
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?start_search=1&firmlegalnam=ReWalk&postdatefrom=01/01/2016&postdateto=12/31/2018
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?start_search=1&firmlegalnam=ReWalk&postdatefrom=01/01/2016&postdateto=12/31/2018
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Details
Incident Context & FAQ
What happened in ReWalk (now Lifeward) recalls Personal 6.0 exoskeleton after tibia and fibula injury complaints?
ReWalk Robotics received complaints of tibia and fibula injury associated with use of the ReWalk Personal 6.0 powered exoskeleton (distributed Sept 2015 to Sept 2017). ReWalk rebranded to Lifeward in 2024. Source: FDA Class 2 device recall Z-0944-2018 (127 units; device K160987), accessdata.fda.gov.
When did this incident occur?
The incident is recorded as occurring on August 14, 2017 on the DEPLOY registry. The date reflects the underlying real-world event, not the registry record's creation date.
What robot was involved in ReWalk (now Lifeward) recalls Personal 6.0 exoskeleton after tibia and fibula injury complaints?
ReWalk Personal 6.0 by Lifeward is the recorded robot involved in this incident at Marlborough.
Has anyone responded to ReWalk (now Lifeward) recalls Personal 6.0 exoskeleton after tibia and fibula injury complaints?
No responses to this incident are recorded on the DEPLOY registry. Operators, manufacturers, or affected parties can submit responses to the editorial team; absence is not a guarantee no response was issued.
What is the current status of ReWalk (now Lifeward) recalls Personal 6.0 exoskeleton after tibia and fibula injury complaints?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.