Surgify Medical recalls Halo 5.4mm extendable surgical tools due to potential burr breakage during spinal procedures. Affected models include 54.000.SEE.H1 with UDI 06429830116998.
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Surgify Medical is recalling their Halo 5.4mm extendable surgical tools because they might break during spinal surgery, which could cause injury. This affects surgeons and medical staff using these tools in specific procedures.
The surgical tools could break during spinal surgery, potentially causing injury to patients or the surgical team. This breakage risk occurs specifically when using the tools in bi-portal endoscopic spinal procedures.
Surgeons and medical staff using the Surgify Halo 5.4mm extendable tools during bi-portal endoscopic spinal surgery (BESS) are most at risk. The recall applies to all units produced until the updated instructions are implemented.
Check for the model number 54.000.SEE.H1 on the product. The recall covers all units with the unique device identifier (UDI) 06429830116998 until updated instructions are implemented.
Look for the model number 54.000.SEE.H1 and UDI 06429830116998 on the product packaging or label.
The Surgify Halo 5.4mm extendable tools have a potential risk of burr breakage during bi-portal endoscopic spinal surgery (BESS), which could cause injury.
Check for the model number 54.000.SEE.H1 and unique device identifier (UDI) 06429830116998 on the product packaging or label.
The recall requires checking the product details but does not specify an immediate stop-use action. Surgeons 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-2564-2026 — Surgify Medical Surgify Medical Hello, I own a Surgify Medical that is covered by recall Z-2564-2026 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.
