Recall Z-1698-2024— Advanced Research Medical, LLC
Class II · Completed
Class II FDA medical device recall by Advanced Research Medical, LLC, initiated 2023-03-14. It names one FDA 510(k) clearance: K173947. Product: ADVANCED RESEARCH MEDICAL Lumbar Interbody Fusion System (OLLIF), Flexible Curette Loop Blade, Part # 01-06-4; treatment of degenerative disc disease. Reason: Potential shearing of the disposable blade may occur and be contained within the of Flexible Curette Shaft Assembly during surgery..
- Recalling firm
- Advanced Research Medical, LLC
- Classification
- Class II
- Status
- Completed
- Initiated
- 2023-03-14
- Firm location
- Burnsville, MN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.