Z-0944-2018 Class II Terminated
FDA device recall Z-0944-2018 was initiated by Argo Medical Technologies Ltd on August 14, 2017 and is designated Class II. Reason for recall: Firm received complaints for ReWalk Personal 6.0 of an injury to tibia and fibula. The recall status is terminated (terminated November 12, 2019). Affected quantity: 127.
Recall Details
- Product Type
- Devices
- Report Date
- March 21, 2018
- Initiation Date
- August 14, 2017
- Termination Date
- November 12, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 127
Product Description
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 Pattern
US and foreign.
Code Information
Date range of Distribution: 09/01/2015 to 09/06/2017.