FDA recall Z-1698-2024

Advanced Research Medical, LLC · Class II · device

Product

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

US Nationwide distribution in the state of Minnesota.

Key facts

Status
Completed
Initiation date
2023-03-14
Report date
2024-05-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
Burnsville, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1698-2024