The FDA announced on March 13, 2018, that Medtronic Sofamor Danek USA Inc is recalling specific Prestige LP Cervical Disc System drill guides due to the risk of drill bit breakage during use. The agency classified this as a Class II recall.
How to tell if you have it
- Brand: Medtronic
- Product: Medtronic Prestige LP(TM) Cervical Disc System with Streamlined Instruments, DRILL GUIDES
- REF 6975205, 5mm; UDI 00643169752979 Lot Number ID17K018
- REF 6975206, 6mm; UDI 00643169752962 Lot Number ID17J009
- REF 6975207, 7mm; UDI 00643169752955 Lot Numbers: ID17K007, ID17L035
The hazard
The firm received complaints of drill bits breaking during use with the Prestige LP(TM) Cervical Disc System. Subsequent investigation demonstrated the interaction of the drill guide and the drill bit may lead to drill bit breakage.
Context
GovInfoNow's records show Medtronic Sofamor Danek USA Inc has 19 other recalls on record since 2017-12-06. Other recent recalls of similar products include Medtronic 6069073 (2025-09-16), Grafton DMB Matrix for Tyvek Pouch Inspection Issue (2023-09-26), and Magnifuse Bone Graft Recall: Incorrect Labeling Risk (2023-07-31). Other recent recalls of similar products include Surgify Halo 5.4mm Medium Drills Risk of Burr Breakage During Spinal Surgery (2026-04-30), Surgify Halo 5.4mm Drill Risk: Burr Breakage During Spinal Surgery (2026-04-30), and Surgify Halo 5.4mm Extendable Drills Risk of Burr Breakage During Spinal Surgery (2026-04-30).