Z-1698-2024 Class II
FDA device recall Z-1698-2024 was initiated by Advanced Research Medical, LLC on March 14, 2023 and is designated Class II. Reason for recall: Potential shearing of the disposable blade may occur and be contained within the of Flexible Curette Shaft Assembly during surgery. Affected quantity: 1150 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 8, 2024
- Initiation Date
- March 14, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1150 units
Product Description
ADVANCED RESEARCH MEDICAL Lumbar Interbody Fusion System (OLLIF), Flexible Curette Loop Blade, Part # 01-06-4; treatment of degenerative disc disease
Reason for Recall
Potential shearing of the disposable blade may occur and be contained within the of Flexible Curette Shaft Assembly during surgery.
Distribution Pattern
US Nationwide distribution in the state of Minnesota.
Code Information
UDI/DI 00850014575311, Lot Numbers: 87458, BB059AA, BB140AA, BB140AB, BB307AA, BB350AA, BC061AA, BC130AA, BC130AA-2, BC274AA, BD083AA, BD083AB, BD083AC