Surgify Medical recalls Halo 3.0mm extendable surgical tools due to potential burr breakage during spinal procedures. Affected units include specific model and catalog numbers.
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Surgify Medical is recalling its Halo 3.0mm extendable surgical instruments because they could break during spinal surgery, potentially causing injury. This affects specific models and lots sold with a unique identifier.
The surgical 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 procedures (BESS).
Surgical teams using the Surgify Halo 3.0mm extendable model (catalog number 30.000.SEE.U2) for spinal procedures are most at risk. Patients undergoing bi-portal endoscopic spinal surgery (BESS) may be affected.
Check for the model number 30.000.SEE.U2 on the Surgify Halo 3.0mm extendable instruments. The unique identifier (UDI) 06429811532229 applies to all affected units until the manufacturer updates the instructions.
Look for the model number 30.000.SEE.U2 on the Surgify Halo 3.0mm extendable instruments.
Reach out to Surgify Medical for guidance on next steps after identifying the affected product.
The Surgify Halo 3.0mm extendable instruments could break during spinal surgery, potentially causing injury to patients.
Check the model number and contact Surgify Medical for guidance on next steps.
The recall applies to all units until the manufacturer updates the instructions, but no specific deadline is stated.
We’ve drafted a message you can send Surgify Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2555-2026 — Surgify Medical Surgify Medical Hello, I own a Surgify Medical that is covered by recall Z-2555-2026 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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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.