Surgify Medical Oy: Drills, Burrs, Trephines & Accessories (simple, Powered)
Surgify Halo 4.0 mm Drill Recall Summary Surgify Medical is recalling Halo 4.0 mm extendable drills and related accessories used in spinal surgery because the burr (cutting tip) may break during use. The product was distributed nationwide to healthcare facilities in multiple states. A burr breaking during spinal surgery could complicate the procedure or cause unintended tissue damage.
- Recalling firm
- SURGIFY MEDICAL OY
- Product
- Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.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/9529b053-ac13-4929-bc39-8c035d2b9613