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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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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