The Recall Desk
SevereFDA (Devices)·Z-0944-2018·Announced 2018-03-21

Argo Medical Recalls ReWalk Personal 6.0 Exoskeletons Due to Leg Injury

Argo Medical Technologies is recalling 127 ReWalk Personal 6.0 exoskeletons after receiving complaints of tibia and fibula injuries.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a Class II medical device with reported injuries to the tibia and fibula, which constitutes significant injury reports under the severity rubric.

Plain-English summary

Argo Medical Technologies Ltd is recalling 127 units of the ReWalk Personal 6.0 exoskeleton, catalog number 50-20-0004. The recall was initiated after the firm received complaints regarding injuries to the tibia and fibula.

The affected devices were distributed in the United States and foreign markets between September 1, 2015, and September 6, 2017. The U.S. Food and Drug Administration has classified this as a Class II recall.

Consumers who possess this device should contact Argo Medical Technologies for instructions on how to proceed with the recall.

The recalled product

Product
ReWalk Personal 6.0. Catalog number: 50-20-0004.
Manufacturer
Argo Medical Technologies Ltd
Category
Medical Device — Mobility Aid
Hazard
Affected units
127

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Date range of Distribution: 09/01/2015 to 09/06/2017.

Distribution

Distribution scope not specified by the agency.

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