Surgify Medical recalls Halo 5.4mm surgical drills due to potential burr breakage during spinal procedures. Affected models include 54.140.SHD.U1 with UDI 06429811532335. No remedy specified in recall notice.
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Surgify Medical is recalling their Halo 5.4mm surgical drills and related tools because they could break during spinal surgery, potentially causing injury. This recall affects specific models sold with a unique identifier. The company has not yet provided a fix or replacement plan.
The drills, burrs, and trephines could break during spinal surgery, which might cause injury to the patient. This risk occurs specifically in bi-portal endoscopic spinal surgery (BESS) procedures where the device is used.
Surgical teams using the Surgify Halo 5.4mm drill model 54.140.SHD.U1 for spinal procedures are most at risk. Patients undergoing bi-portal endoscopic spinal surgery (BESS) may be affected if the device breaks during the procedure.
Check for the model number 54.140.SHD.U1 on the device or packaging. The unique device identifier (UDI) 06429811532335 is also associated with this recall. All units sold until the manufacturer updates the instructions are affected.
Look for the model number 54.140.SHD.U1 on the device or its packaging.
The recall notice does not specify any remedy or fix for the burr breakage problem.
Check for the model number 54.140.SHD.U1 or the unique device identifier (UDI) 06429811532335 on the device or packaging.
The recall does not provide a specific instruction to stop using the device immediately, but affected units should be checked for the model number.
We’ve drafted a message you can send Surgify Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2573-2026 — Surgify Medical Surgify Medical Hello, I own a Surgify Medical that is covered by recall Z-2573-2026 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.
