FDA recall Z-0944-2018
Argo Medical Technologies Ltd · Class II · device
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.
Distribution
US and foreign.
Key facts
- Status
- Terminated
- Initiation date
- 2017-08-14
- Report date
- 2018-03-21
- Termination date
- 2019-11-12
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Haifahaifa, Israel
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0944-2018