Surgify Medical Oy: Drills, Burrs, Trephines & Accessories (simple, Powered)
Recall Summary Surgify Medical is recalling their Halo 5.4 mm Long surgical drill burr (Model 54.140.SHD.U1) used in spinal surgery because the burr may break during use. The product was distributed nationwide across the United States. This is a Class II recall, meaning the defect could cause serious injury but is not likely to be fatal.
- Recalling firm
- SURGIFY MEDICAL OY
- Product
- Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.140.SHD.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/17b81b41-e721-4e41-9d98-7e52aa2167a7