- Recalling firm
- SURGIFY MEDICAL OY
- Reason for recall
- Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
- Affected products (lot / model / serial)
- UDI06429811532069; All lots until the IFU update has been implemented
- Units affected
- N/A
- Distribution pattern
- US Nationwide distribution in the states of MN, MA, IN, LA, CA, NY, FL.
- Firm location
- Espoo, N/A, Finland
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- E-Mail
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2560-2026
- Recall initiated
- April 30, 2026
- FDA classification date
- June 24, 2026
- FDA report date
- July 1, 2026
- FDA event ID
- 98918
- Last updated on HTM Vibe
- July 23, 2026