Surgify Medical Oy: Drills, Burrs, Trephines & Accessories (simple, Powered)
Surgify Halo Drill Burr Recall Surgify Medical is recalling Halo 5.4 mm Medium drill burrs (Model 54.085.SHD.U1) used in spinal surgery because the burrs may break during use. The burrs were distributed nationwide to hospitals and surgical facilities. Healthcare providers who have these burrs should check their inventory and follow the manufacturer's instructions regarding use and replacement.
- Recalling firm
- SURGIFY MEDICAL OY
- Product
- Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.U1; drills, 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/8c539a72-1f74-4a05-af58-353cb8f3173f