FDA Medical Device Recalls (openFDA)
SURGIFY MEDICAL OY: Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.H1; drills, burrs, trephines & accessories (simple, powered)
- Recall number
- Z-2564-2026
- Recalling firm
- SURGIFY MEDICAL OY
- Product
- Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.H1; drills, burrs, trephines & accessories (simple, powered)
- Status
- Open, Classified
- Initiated
- 2026-04-30
- Posted
- 2026-06-24
- Terminated
- not on file
- Reason
- Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
- 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 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
- 53 units
- Distribution
- US Nationwide distribution in the states of MN, MA, IN, LA, CA, NY, FL.
- Lot, serial or model codes
- UDI: 06429830116998 ; All lots until the IFU update has been implemented
- 510(k) numbers
- ["K250380"]
- PMA numbers
- not on file
- Product code
- HBE
- Firm FEI
- 3015392173
- Firm city
- Espoo
- Firm state
- not on file
- Firm country
- Finland
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28