Surgify Medical recalls Halo 5.4mm drills and accessories due to potential burr breakage during spinal surgery. Affected units include model 54.125.NVG.U1 with UDI 0642981:11532304.
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Surgify Medical is recalling specific Halo 5.4mm drills and accessories used in spinal surgery because they might break during procedures. This could lead to complications for patients undergoing bi-portal endoscopic spinal surgery.
The drills and burrs could break during spinal surgery, potentially causing injury to the patient. This risk occurs specifically in bi-portal endoscopic spinal surgery (BESS) procedures where the tools are used.
Healthcare professionals using the Surgify Halo 5.4mm model for spinal surgery are most at risk. Patients undergoing bi-portal endoscopic spinal procedures may be affected if the recalled tools are used.
Check for the model number 54.125.NVG.U1 on the Surgify Halo 5.4mm drill. The product also includes drills, burrs, trephines, and accessories. All units with the unique device identifier (UDI) 06429811532304 are affected.
Verify the model number on the product label to confirm if it matches 54.125.NVG.U1.
Reach out to Surgify Medical for further guidance on the recall and potential remedies.
The Surgify Halo 5.4mm drills and accessories have a potential risk of burr breakage during bi-portal endoscopic spinal surgery (BESS).
Check the model number and UDI on the product. Contact Surgify Medical for specific instructions.
The recall record does not specify a deadline for action.
We’ve drafted a message you can send Surgify Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2571-2026 — Surgify Medical Surgify Medical Hello, I own a Surgify Medical that is covered by recall Z-2571-2026 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.