Z-2558-2026Class II
Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.H1; drills, burrs, trephines & accessories...
Surgify Medical Oy / initiated 2026-04-30 / Open, Classified
SURGIFY MEDICAL OY began a recall of Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.H1; drills, burrs, trephines & accessories (simple, powered) on . FDA classified it as Class II and gives the reason as "Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS)". As of , the recall status on record is Open, Classified.
Recall record
- Recall number
- Z-2558-2026
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Surgify Medical Oy
- Product
- Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.H1; drills, burrs, trephines & accessories (simple, powered)
- Product code
- HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
- Reason for recall
- Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
- FDA root cause
- Under Investigation by firm
- Action
- Surgify issued a Medical Device Correction Notice - Surgify Halo - Restriction of Use notice to its consignees on 4/30/2026 via email. The notice explained the issue, potential risk, and requested the following: "What steps must the user take? Please review your current practice and ensure the device is only used in accordance with the updated safety information. Instruction to Customers: The customers have been instructed to do the following: - Do not use this device in endoscopic surgical procedures. If endoscopic access is required, an alternative instrument should be selected. Specifically: . Do not use this device in endoscopic surgical procedures. If endoscopic access is required, an alternative instrument should be selected. . Ensure that all relevant clinical staff and surgical team members are made aware of this notice. . Please retain this notice for your records and attach it to the relevant product documentation. Please acknowledge receipt of this Medical Device Correction Notice by replying to [email protected] within 30 business days, confirming that the notice has been read, understood, and communicated to all relevant users within your organization. Please include your facility name, your name, and your role. If you have previously used the device in endoscopic procedures without incident, no patient follow-up is required; however, this application should now be discontinued in line with the updated safety information." For questions regarding this matter, please contact us by phone at +358 105 176 310 or via email at [email protected].
- Quantity in commerce
- 112 units
- Distribution
- US Nationwide distribution in the states of MN, MA, IN, LA, CA, NY, FL.
- Product codes and lots
- UDI: 06429811532076; All lots until the IFU update has been implemented
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2555-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2556-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2557-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2558-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2559-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2560-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2561-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2562-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2563-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2564-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2565-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2566-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2567-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2568-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2569-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2570-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2571-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2572-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2573-2026 | Class II | Ongoing | Voluntary: Firm initiated |
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