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Use caution Medical device recall · FDA · Published August 14, 2017

ReWalk Personal 6.0 Recall: Injury Reports to Tibia and Fibula

Argo Medical recalls ReWalk Personal 6.0 (catalog 50-20-0004) sold 2015-2017 after injury reports to tibia and fibula. Consumers should check if their device falls within the date range.

🇺🇸 FDA recall #Z-0944-2018Medical deviceArgo Medical ›
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Recalling firmArgo Medical Technologies LtdMatambuilding 30p.O.Box 15054 · Haifahaifa, Israel
✎ GovInfoNow plain-language explainer

What happened, in plain English

Argo Medical is recalling ReWalk Personal 6.0 devices that were sold between September 2015 and September 2017. The recall is due to reports of injuries to the tibia and fibula bones. This is a serious safety issue that requires attention. Read more at govinfonow.com/recall/73142-rewalk-personal-6-0-recall-injury-reports-to-tibia-and.

Source Summary by GovInfoNow · govinfonow.com/recall/73142-rewalk-personal-6-0-recall-injury-reports-to-tibia-and · Updated September 23, 2026 · FDA enforcement record: FDA #Z-0944-2018

Cite this page

“ReWalk Personal 6.0 Recall: Injury Reports to Tibia and Fibula.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/73142-rewalk-personal-6-0-recall-injury-reports-to-tibia-and. Based on FDA recall #Z-0944-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0944-2018%22&limit=1).

Why it’s dangerous

The ReWalk Personal 6.0 has been reported to cause injuries to the tibia and fibula bones. This likely happens when the device's movement or weight distribution places excessive stress on the lower leg during use.

Who’s affected

People who own or use ReWalk Personal 6.0 devices purchased between September 2015 and September 2017 are affected. Those with mobility impairments or who use the device for rehabilitation are at higher risk.

How to tell if you have this one

Check if your ReWalk Personal 6.0 has catalog number 50-20-0004. Devices were sold between September 2015 and September 2017.

  • Brand
    Argo Medical
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Device Details

    Identify if your ReWalk Personal 6.0 has catalog number 50-20-0004 and was purchased between September 2015 and September 2017.

How this recall unfolded

Recall timeline

FDA terminated this recall 2.2 years after the firm started it.

1. Firm started the recall: Aug 14, 201712. FDA classified it Class II: Mar 9, 201823. Published in FDA’s Enforcement Report: Mar 21, 201834. FDA terminated the recall: Nov 12, 2019420172019
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-0944-2018 (August 14, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0944-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on September 23, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA