ADVANCED RESEARCH MEDICAL Lumbar Interbody Fusion System… recallZ-1698-2024 · Advanced Research Medical, LLC · initiated Mar 14, 2023
Completed
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Advanced Research Medical, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Potential shearing of the disposable blade may occur and be contained within the of Flexible Curette Shaft Assembly during surgery.
FDA root cause category: Device Design
What the company is doing
The sole distributor was notified by emailed letter of updates to the Surgical Technique Guide and IFU on 14 March 2023. The IFU has been updated to address a few small details including the direct listing of single use disposable components and the definition of single use being for one level only. The surgical technique guide has improved graphics, more thorough descriptions for some of the instrument assembly steps that your scrub techs may find useful and a statement regarding the appropriate use of the Flexible Curette Blade to prevent surgeons from using it in a way that may overstress the blade and cause a break. This information was shared with the surgeons through the sole distributor.
Recall details
- Recall number
- Z-1698-2024
- Status
- Completed
- Initiated by the company
- Mar 14, 2023
- Posted by the FDA
- Apr 29, 2024
- Recalling firm
- Advanced Research Medical, LLC
- Quantity
- 1150 units
- Product code
- MAX
- FDA submissions
- K173947
- Distribution
- US Nationwide distribution in the state of Minnesota.
Product description
ADVANCED RESEARCH MEDICAL Lumbar Interbody Fusion System (OLLIF), Flexible Curette Loop Blade, Part # 01-06-4; treatment of degenerative disc disease
Code information (models, lots, serial numbers)
UDI/DI 00850014575311, Lot Numbers: 87458, BB059AA, BB140AA, BB140AB, BB307AA, BB350AA, BC061AA, BC130AA, BC130AA-2, BC274AA, BD083AA, BD083AB, BD083AC
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Lumbar Interbody Fusion System (OLLIF) 01-06-4Advanced Research Medical LLC · Intervertebral Fusion Device With Bone Graft, Lumbar1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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