Surgify Halo | 3.0 mm | Extendable 30.000.SEE.U2Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 06429811532229), received between Jun 23, 2026 and Jun 23, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Apr 30, 2026Class IIOpen, Classified

   Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

   Z-2555-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 23, 2026Detachment of Device or Device Component

  DURING A SPINE PROCEDURE THE BURR DISASSEMBLED. THE USE TIME OF THE DEVICE EXCEEDED APPROXIMATELY 6 TIMES THE USE TIME SPECIFIED IN THE IFU. ALSO 50% HIGHER RPM WAS USED COMPARED TO THE RPM STATED IN THE IFU. NO REPORTED HARM WAS CAUSED TO THE PATIENT. POST-OPERATIVE PICTURES (TAKEN FOR OTHER REASONS) CONFIRMED THAT NO BURR FRAGMENTS REMAINED IN THE BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25589715 ↗