Surgify Medical Oy: Drills, Burrs, Trephines & Accessories (simple, Powered)
Recall Summary Surgify Medical is recalling Halo 5.4 mm Extendable drills and related surgical accessories (Model 54.000.SEE.U1) used in spinal surgery because the burr component may break during the procedure. The affected devices were distributed nationwide across the United States.
- Recalling firm
- SURGIFY MEDICAL OY
- Product
- Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.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/d9057f00-553a-4d22-8340-c9cd1ee1ef78