Surgify Halo 5.4mm Medium: Burr Breakage Risk in Spinal Surgery

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Recalling firmSURGIFY MEDICAL OYOtakaari 5 I, N/A · Espoo, N/A N/A

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Surgify Medical is recalling specific spinal surgery tools that could break during procedures, potentially causing injury. This recall affects surgeons using the 5.4mm Medium Halo model and related accessories.

Why it’s dangerous

The surgical tools could break during spinal procedures, which might lead to complications like tissue damage or bleeding. This risk occurs specifically when the tools are used in bi-portal endoscopic spinal surgery (BESS).

Who’s affected

Surgeons and medical professionals using the Surgify Halo 5.4mm Medium model (catalog number 54.085.SHD.H1) and related surgical tools. Those performing bi-portal endoscopic spinal surgery (BESS) are most at risk.

How to tell if you have this one

Check for the model number 54.085.SHD.H1 on the Surgify Halo 5.4mm Medium tools. The recall covers all units until the manufacturer updates the instructions for use.

Brand
Surgify Medical
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Look for the model number 54.085.SHD.H1 on the Surgify Halo 5.4mm Medium tools and related accessories.

✎ GovInfoNow

Questions people ask

Is there a fix for this issue?

The official recall notice does not specify a remedy.

What is the specific hazard with these tools?

The tools could break during bi-portal endoscopic spinal surgery (BESS), potentially causing injury.

Which medical procedures are affected?

This recall applies to surgeons performing bi-portal endoscopic spinal surgery (BESS) using the specific model.

Take action

Contact Surgify Medical

We’ve drafted a message you can send Surgify Medical to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-2568-2026 — Surgify Medical Surgify Medical

Hello,

I own a Surgify Medical that is covered by recall Z-2568-2026 from Surgify Medical.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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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-2568-2026 (April 30, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2568-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 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.

SURGIFY MEDICAL OY recalls Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.H1; burrs, trephines & accessories (simple, powered)

Recall notice