Surgify Medical Oy: Drills, Burrs, Trephines & Accessories (simple, Powered)
Recall Summary Surgify Medical is recalling Surgify Halo 5.4mm Long drills and related surgical accessories because the burr (cutting tool) may break during spinal surgery. The product was distributed nationwide across the United States. This is a Class II recall, meaning the product could cause serious injury or illness but is not expected to cause death.
- Recalling firm
- SURGIFY MEDICAL OY
- Product
- Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.140.SHD.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/73424781-0165-4d09-b3e2-61d417550ac3