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Terminated

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

FDA Recall Z-0944-2018 · Posted None

Recalling FirmArgo Medical Technologies Ltd
Recall StatusTerminated
Product CodePHL
Date Initiated2017-08-14
Date Terminated2019-11-12
Product Quantity127

Reason for Recall

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

Firm Action

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

Root Cause

Other

Distribution Pattern

US and foreign.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K160987ReWalk(TM)Rewalk Robotics, Inc. · 2016-07-22

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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