Recall Z-0944-2018

Argo Medical Technologies Ltd · initiated August 14, 2017

Class II Terminated

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

ReWalk Personal 6.0. Catalog number: 50-20-0004.

Codes / lots: Date range of Distribution: 09/01/2015 to 09/06/2017.

Reason for recall

Firm received complaints for ReWalk Personal 6.0 of an injury to tibia and fibula.

FDA-determined cause: Other

Action taken

Customers were notified via letter on 08/14/2017.

Details

Recall number
Z-0944-2018
Initiated
August 14, 2017
Terminated
November 12, 2019
Product code
PHL – Powered Exoskeleton
Quantity
127
Distribution
US and foreign.
Recalling firm
Argo Medical Technologies Ltd, Haifahaifa

Official FDA recall record