FDAClass IIMay 8, 2024

ADVANCED RESEARCH MEDICAL Lumbar Interbody Fusion recall

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

Why was ADVANCED RESEARCH MEDICAL Lumbar Interbody Fusion recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI/DI 00850014575311, Lot Numbers: 87458, BB059AA, BB140AA, BB140AB, BB307AA, BB350AA, BC061AA, BC130AA, BC130AA-2, BC274AA, BD083AA, BD083AB, BD083AC

Product
ADVANCED RESEARCH MEDICAL Lumbar Interbody Fusion System (OLLIF), Flexible Curette Loop Blade, Part # 01-06-4; treatment of degenerative disc disease
Recalling firm
Advanced Research Medical, LLC
Quantity
1150 units
Distribution
US Nationwide distribution in the state of Minnesota.
Recall date
May 8, 2024
Classification
Class II
Status
Completed
Agency
FDA (device)
Open FDA enforcement record Latest recalls