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Incident · Recall

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.

Occurred 2017-08-14 · ReWalk Personal 6.0 at Marlborough · Lifeward · Marlborough · Exoskeletons · Investigated by FDA

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Incident records on DEPLOY are compiled from public sources (regulatory filings, news reports, and operator disclosures) and reflect what has been reported and tracked to date. They are not legal findings, determinations of fault, or safety ratings, and may be updated as new information is verified. See the sources below for the underlying references.
Track ReWalk (now Lifeward) recalls Personal 6.0 exoskeleton after tibia and fibula injury complaints

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Sources (1)

  1. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?start_search=1&firmlegalnam=ReWalk&postdatefrom=01/01/2016&postdateto=12/31/2018

Common questions

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.
Methodology: Verified · 1 source (1 primary) · last reviewed 2026-08-09

Verification posture

Verified

High confidence

Review state

Stable

Last reviewed 2026-08-09

Sources by quality tier

1
primary-fda-database
FDA database

The framework is documented at /methodology. Corrections at /corrections. Reviewer: DEPLOY editorial team.

Methodology surface for ReWalk (now Lifeward) recalls Personal 6.0 exoskeleton after tibia and fibula injury complaints.

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Canonical ID 21b2e025-7878-41cf-847c-921ba5ab2781