ReWalk Personal 6 — Class II medical device recall Z-0944-2018
Terminated recall by Argo Medical Technologies Ltd, reported 2018-03-21. Firm received complaints for ReWalk Personal 6.0 of an injury to tibia and fibula.
| Recall number | Z-0944-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Argo Medical Technologies Ltd, Haifahaifa, Israel |
| Recall initiated | 2017-08-14 |
| Classified | 2018-03-09 |
| Reported by FDA | 2018-03-21 |
| Terminated | 2019-11-12 |
| Quantity | 127 |
| Model numbers | 50-20-0004 |
Product
ReWalk Personal 6.0. Catalog number: 50-20-0004.
Reason for recall
Firm received complaints for ReWalk Personal 6.0 of an injury to tibia and fibula.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0944-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.