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Surgify Halo | 5.4 mm | Extendable recallZ-2564-2026 · Surgify Medical Oy · initiated Apr 30, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Surgify Medical Oy or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Under Investigation by firm

What the company is doing

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].

Recall details

Recall number
Z-2564-2026
Status
Open, Classified
Initiated by the company
Apr 30, 2026
Posted by the FDA
Jun 24, 2026
Recalling firm
Surgify Medical Oy
Quantity
53 units
Product code
HBE
FDA submissions
K250380
Distribution
US Nationwide distribution in the states of MN, MA, IN, LA, CA, NY, FL.

Product description

Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.H1; drills, burrs, trephines & accessories (simple, powered)

Code information (models, lots, serial numbers)

UDI: 06429830116998 ; All lots until the IFU update has been implemented

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 98918).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page