Surgify Medical recalls Halo 5.4mm extendable surgical tools due to potential burr breakage during spinal procedures. Affected models include 54.000.SEE.U1 with UDI 06429811532311.
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Surgify Medical is recalling their Halo 5.4mm extendable surgical tools because burrs could break during spinal surgery. This poses a risk of injury to patients during bi-portal endoscopic spinal procedures.
Burr breakage during spinal surgery could cause tissue damage or injury to the patient. The hazard occurs when the burr breaks while being used in bi-portal endoscopic spinal procedures (BESS).
Surgical teams using the specific model (54.000.SEE.U1) for spinal procedures are most at risk. Patients undergoing bi-portal endoscopic spinal surgery may be affected.
Check for the model number 54.000.SEE.U1 on the product. The product has a unique device identifier (UDI) of 06429811532311. These items were sold with the original instructions until the updated instructions were implemented.
Identify the model number and UDI to confirm if your item is affected.
The product is not safe for use until the updated instructions are implemented. Affected items should not be used until the manufacturer provides the fix.
The manufacturer has not provided specific instructions for affected products. Check the product details to confirm if it is affected.
The official recall notice does not mention replacement options. Affected products should be checked against the model number and UDI.
We’ve drafted a message you can send Surgify Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2565-2026 — Surgify Medical Surgify Medical Hello, I own a Surgify Medical that is covered by recall Z-2565-2026 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.
