Surgify Halo 5.4mm Drill Risk: Burr Breakage During Spinal Surgery

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Contact the company & request your remedy

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 drills that could break during procedures, risking injury to patients. This is a serious hazard for surgeons using these tools in spinal surgeries.

Why it’s dangerous

The drills can break during spinal surgery, potentially causing injury to the patient. This breakage risk occurs specifically when using the drills in bi-portal endoscopic spinal surgery (BESS) procedures.

Who’s affected

Surgeons and medical facilities using the recalled Surgify Halo 5.4mm drills for spinal procedures are most at risk. Patients undergoing BESS (bi-portal endoscopic spinal surgery) may be affected if the drill breaks during their procedure.

How to tell if you have this one

Check for the model number 54.140.SHD.H1 on the Surgify Halo 5.4mm drill. The product was sold with the UDI 06429811532137. All lots until the IFU update are affected.

Brand
Surgify Medical
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Stop Using Drills Now
Immediately stop using the recalled Surgify Halo 5.4mm drills if you have them. The hazard can cause serious injury during spinal surgery.

✎ GovInfoNow

Questions people ask

Why is this drill being recalled?

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

What model numbers are affected?

The affected model is 54.140.SHD.H1 with the UDI 06429811532137.

How do I know if I have the recalled product?

Check for the model number 54.140.SHD.H1 on the drill. All lots until the IFU update are affected.

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-2572-2026 — Surgify Medical Surgify Medical

Hello,

I own a Surgify Medical that is covered by recall Z-2572-2026 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-2572-2026 (April 30, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2572-2026 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, Long, Model/Catalog Number: 54.140.SHD.H1; drills, burrs, trephines & accessories (simple,

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