Surgify Medical Oy: Drills, Burrs, Trephines & Accessories (simple, Powered)
Recall Summary Surgify Medical is recalling Halo 4.0 mm Extendable drills and related surgical accessories used in spinal surgery because the burr (cutting tool) may break during use. The product was distributed nationwide to hospitals and surgical facilities. A broken burr during surgery could complicate the procedure, though this is classified as a moderate-risk recall.
- Recalling firm
- SURGIFY MEDICAL OY
- Product
- Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.H1; 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/cb9638e2-53a8-4ecc-a131-8785cbebc880