Surgify Medical Oy: Drills, Burrs, Trephines & Accessories (simple, Powered)
Recall Summary Surgify Medical is recalling the Halo 5.4 mm Extendable drill burr (Model 54.000.SEE.H1) used in spinal surgery because the burr may break during use. The product was distributed nationwide across the United States. Healthcare facilities that use this device should check if they have it in stock.
- Recalling firm
- SURGIFY MEDICAL OY
- Product
- Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.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/00e3e185-1a55-45f1-b79c-bf83ddec6089