Surgify Medical recalls Halo 5.4mm Medium surgical tools due to potential burr breakage during spinal procedures. Affected items include specific model numbers and lots. Contact for remedy details.
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Surgify Medical is recalling certain Halo 5.4mm Medium surgical tools because they might break during spinal surgery, which could cause injury. This recall affects specific model numbers and lots sold to medical professionals.
The surgical tools could break during spinal surgery, potentially causing injury to the patient. This breakage risk occurs specifically during bi-portal endoscopic spinal procedures.
Medical professionals using the recalled surgical tools are most at risk. Patients undergoing bi-portal endoscopic spinal surgery (BESS) may be affected if the tools are used.
Check for the model number 54.085.SHD.U1 on the tool or packaging. The recall covers all lots until the manufacturer updates the instructions for use.
Look for the model number 54.085.SHD.U1 on the tool or packaging.
The recall is due to potential burr breakage during bi-portal endoscopic spinal surgery (BESS), which could cause injury.
Check the model number on the tool or packaging. If it matches 54.085.SHD.U1, contact Surgify Medical for further instructions.
The recall covers all lots until the manufacturer updates the instructions for use, 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-2569-2026 — Surgify Medical Surgify Medical Hello, I own a Surgify Medical that is covered by recall Z-2569-2026 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.
