Device product
ADVANCED RESEARCH MEDICAL Lumbar Interbody Fusion System (OLLIF), Flexible Curette Loop Blade, Part # 01-06-4; treatment of degenerative disc disease
Z-1698-2024
Product summary
- Event
- Event 94279
- Status
- Completed
- Classification
- Class II
- Quantity
- 1150 units
- Official record key
device-enforcement:Z-1698-2024
Official wording
Reason: Potential shearing of the disposable blade may occur and be contained within the of Flexible Curette Shaft Assembly during surgery.
Code information: UDI/DI 00850014575311, Lot Numbers: 87458, BB059AA, BB140AA, BB140AB, BB307AA, BB350AA, BC061AA, BC130AA, BC130AA-2, BC274AA, BD083AA, BD083AB, BD083AC
Distribution pattern: US Nationwide distribution in the state of Minnesota.
Derived failure modes
-
Unknown
Potential shearing of the disposable blade may occur and be contained within the of Flexible Curette Shaft Assembly during surgery.