Medical device recalls Moderate risk

Argo Medical Technologies Ltd recalls ReWalk Personal 6.0. Catalog number: 50-20-0004.

Recall date
August 14, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0944-2018
FDA classification
Class II
Brand / firm
Argo Medical Technologies Ltd
Sold / distributed
US and foreign.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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