Surgify Halo | 4.0 mm | ExtendableRecalls & reported problems across all models
Surgify Medical Oy · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one Surgify Halo | 4.0 mm | Extendable model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 2
We found 2 models of Surgify Halo | 4.0 mm | Extendable by Surgify Medical Oy in the FDA's device registry (GUDID). Together they are named in 1 adverse event report in the FDA's MAUDE database, received between May 29, 2026 and May 29, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
2 FDA recall records name at least one of these models by its device identifier, 2 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Surgify Halo | 4.0 mm | Extendable recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Apr 30, 2026Open, Classified
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Z-2559-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Apr 30, 2026Open, Classified
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Z-2558-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported Surgify Halo | 4.0 mm | Extendable problems
Device problems
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Surgify Halo | 4.0 mm | Extendable models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Surgify Halo | 4.0 mm | Extendable 40.000.SEE.H1Drills, Burrs, Trephines & Accessories (Simple, Powered)1 recall1 report
- Surgify Halo | 4.0 mm | Extendable 40.000.SEE.U1Drills, Burrs, Trephines & Accessories (Simple, Powered)1 recall0 reports
Recent Surgify Halo | 4.0 mm | Extendable adverse event reports
The 1 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMay 29, 2026Detachment of Device or Device Component
DURING A CLINICAL STUDY PROCEDURE (OPEN SPINAL SURGERY), A SMALL METAL FRAGMENT DISLODGED FROM THE BURR. THE DEVICE STAYED INTACT OTHERWISE; THE FRAGMENT WAS FULLY RETRIEVED INTRAOPERATIVELY, AND NO PATIENT HARM RESULTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25329224 ↗
Other Surgify Medical Oy products
- Surgify Halo | 5.4 mm | Long4 models · 0 reports · 4 recalls
- Surgify Halo | 5.4 mm | Medium2 models · 0 reports · 2 recalls
- Surgify Halo | 5.4 mm | Extendable2 models · 0 reports · 2 recalls
- Surgify Halo | 5.4 mm | Short2 models · 0 reports · 2 recalls
- Surgify Halo | 4.0 mm | Long2 models · 0 reports · 2 recalls
- Surgify Halo | 4.0 mm | Short2 models · 0 reports · 2 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page