FDA Medical Device Recalls (openFDA)
Argo Medical Technologies Ltd: ReWalk Personal 6.0. Catalog number: 50-20-0004.
- Recall number
- Z-0944-2018
- Recalling firm
- Argo Medical Technologies Ltd
- Product
- ReWalk Personal 6.0. Catalog number: 50-20-0004.
- Status
- Terminated
- Initiated
- 2017-08-14
- Posted
- not on file
- Terminated
- 2019-11-12
- Reason
- Firm received complaints for ReWalk Personal 6.0 of an injury to tibia and fibula.
- Root cause
- Other
- Action
- Customers were notified via letter on 08/14/2017.
- Quantity
- 127
- Distribution
- US and foreign.
- Lot, serial or model codes
- Date range of Distribution: 09/01/2015 to 09/06/2017.
- 510(k) numbers
- ["K160987"]
- PMA numbers
- not on file
- Product code
- PHL
- Firm FEI
- 3007615665
- Firm city
- Haifahaifa
- Firm state
- not on file
- Firm country
- Israel
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28