FDA-Device2024-05-08Class II

ADVANCED RESEARCH MEDICAL Lumbar Interbody Fusion System (OLLIF), Flexible Curette Loop Blade, Part # 01-06-4; treatment of degenerative disc disease

Advanced Research Medical, LLC
Hazard

Potential shearing of the disposable blade may occur and be contained within the of Flexible Curette Shaft Assembly during surgery.

Sold states
US Nationwide distribution in the state of Minnesota.
Affected count
1150 units
Manufactured in
1515 Highway 13 E, Burnsville, MN, United States
Products
ADVANCED RESEARCH MEDICAL Lumbar Interbody Fusion System (OLLIF), Flexible Curette Loop Blade, Part # 01-06-4; treatment of degenerative disc disease

Official notice

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

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