Surgify Medical Oy: Drills, Burrs, Trephines & Accessories (simple, Powered)
Recall Summary Surgify Medical is recalling Halo 5.4 mm Medium burrs and related surgical accessories (Model 54.085.SHD.H1) used in spinal surgery because they may break during use. The products were distributed nationwide across the United States. This is a Class II recall, indicating a potential health risk.
- Recalling firm
- SURGIFY MEDICAL OY
- Product
- Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.H1; burrs, trephines & accessories (simple, powered)
- Reason
- Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-04-30
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution in the states of MN, MA, IN, LA, CA, NY, FL.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/1bb67959-8841-43a1-bada-2b2a7fb5bfa0