Surgify Halo 4.0mm Extendable: Burr Breakage Risk in Spinal Surgery

Take action

Contact the company & request your remedy

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

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

Surgify Medical is recalling their Halo 4.0mm extendable surgical instruments because they could break during spinal surgery, potentially causing injury. This affects specific models and lots sold with a unique identifier.

Why it’s dangerous

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

Who’s affected

Surgical teams using the Surgify Halo 4.0mm extendable instruments for spinal procedures are most at risk. Patients undergoing bi-portal endoscopic spinal surgery (BESS) may be affected by the recall.

How to tell if you have this one

Check for the model number 40.000.SEE.H1 and catalog number 40.000.SEE.H1 on the instruments. The unique identifier (UDI) 06429811532076 is also associated with affected units.

Brand
Surgify Medical
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Model Number
Look for the model number 40.000.SEE.H1 on the instruments.
Contact Manufacturer
Reach out to Surgify Medical for guidance on the recall and next steps.

✎ GovInfoNow

Questions people ask

Why is this recall happening?

The recall is due to potential burr breakage during bi-portal endoscopic spinal surgery (BESS), which could cause injury.

What should I do if I have this product?

Check the model number and contact Surgify Medical for guidance on the recall.

Is there a specific time frame for action?

The official notice does not specify a deadline for action.

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-2558-2026 — Surgify Medical Surgify Medical

Hello,

I own a Surgify Medical that is covered by recall Z-2558-2026 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.

Similar recalls

From people who’ve dealt with this

Experiences, tips, and questions from readers. Every comment is reviewed before it appears.

No comments yet — be the first to share your experience.

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-2558-2026 (April 30, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2558-2026 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, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.H1; drills, burrs, trephines & accessories (simple,

Use caution until it’s fixed