Surgify Medical recalls Halo 4.0mm extendable surgical tools due to potential burr breakage during spinal procedures. Affected items have specific model numbers and were sold with certain accessories.
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Surgify Medical is recalling their Halo 4.0mm extendable surgical tools because they could break during spinal surgery, potentially causing injury. This affects specific model numbers and accessories used in bi-portal endoscopic spinal procedures.
The surgical tools could break during spinal surgery, which might cause injury to the patient. This risk occurs specifically when the tools are used in bi-portal endoscopic spinal procedures (BESS).
Surgical teams using the Surgify Halo 4.0mm extendable tools for spinal procedures are most at risk. Patients undergoing bi-portal endoscopic spinal surgery (BESS) with these tools may be affected.
Check for the model number 40.000.SEE.U1 on the Surgify Halo 4.0mm extendable tools. These items were sold with specific accessories and were manufactured until the updated instructions were implemented.
Identify the model number on the Surgify Halo tool; affected items have the specific model 40.000.SEE.U1.
Reach out to Surgify Medical for guidance on next steps after identifying the affected product.
The recall is due to potential burr breakage during bi-portal endoscopic spinal surgery (BESS), which could cause injury.
The affected model number is 40.000.SEE.U1 for the Surgify Halo 4.0mm extendable tools.
The recall does not require immediate stop use; surgical teams should follow updated instructions once available.
We’ve drafted a message you can send Surgify Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2559-2026 — Surgify Medical Surgify Medical Hello, I own a Surgify Medical that is covered by recall Z-2559-2026 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.