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Recall Observatory FDA recall evidence

Device product

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

Z-0944-2018

August 14, 2017

Class II

Product summary

Firm
Argo Medical Technologies Ltd
Event
Event 79186
Status
Terminated
Classification
Class II
Quantity
127
Official record key
device-enforcement:Z-0944-2018

Official wording

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

Code information: Date range of Distribution: 09/01/2015 to 09/06/2017.

Distribution pattern: US and foreign.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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