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U.S. Department of Health and Human Services

Class 2 Device Recall Surgify Halo

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 Class 2 Device Recall Surgify Halosee related information
Date Initiated by FirmApril 30, 2026
Date PostedJune 24, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2558-2026
Recall Event ID 98918
510(K)NumberK251433 
Product Classification Drills, burrs, trephines & accessories (simple, powered) - Product Code HBE
ProductSurgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.H1; drills, burrs, trephines & accessories (simple, powered)
Code Information UDI: 06429811532076; All lots until the IFU update has been implemented
FEI Number 3015392173
Recalling Firm/
Manufacturer		 SURGIFY MEDICAL OY
Otakaari 5 I
Espoo Finland
Manufacturer Reason
for Recall		Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
FDA Determined
Cause 2		Under Investigation by firm
ActionSurgify 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 raqa@surgifymedical.com 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 support@surgifymedical.com.
Quantity in Commerce112 units
DistributionUS Nationwide distribution in the states of MN, MA, IN, LA, CA, NY, FL.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = HBE
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