PlainRecalls
FDA Devices Moderate Class II Completed

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

Reported: May 8, 2024 Initiated: March 14, 2023 #Z-1698-2024

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.

Details

Units Affected
1150 units
Distribution
US Nationwide distribution in the state of Minnesota.
Location
Burnsville, MN

Frequently Asked Questions

What product was recalled?
ADVANCED RESEARCH MEDICAL Lumbar Interbody Fusion System (OLLIF), Flexible Curette Loop Blade, Part # 01-06-4; treatment of degenerative disc disease. Recalled by Advanced Research Medical, LLC. Units affected: 1150 units.
Why was this product recalled?
Potential shearing of the disposable blade may occur and be contained within the of Flexible Curette Shaft Assembly during surgery.
Which agency issued this recall?
This recall was issued by the FDA Devices on May 8, 2024. Severity: Moderate. Recall number: Z-1698-2024.