Z-1698-2024Class II

ADVANCED RESEARCH MEDICAL Lumbar Interbody Fusion System (OLLIF), Flexible Curette Loop Blade, Part #...

Name: Z-1698-2024 ADVANCED RESEARCH MEDICAL Lumbar Interbody Fusion System (OLLIF), Flexible Curette Loop Blade, Part #...
Creator: Advanced Research Medical, LLC
Published: 2023-03-14
License: https://open.fda.gov/license/

Advanced Research Medical / initiated 2023-03-14 / Completed / root cause: design

FDA source

Advanced Research Medical, LLC began a recall of ADVANCED RESEARCH MEDICAL Lumbar Interbody Fusion System (OLLIF), Flexible Curette Loop Blade, Part # 01-06-4; treatment of degenerative disc disease on 2023-03-14. FDA classified it as Class II and gives the reason as "Potential shearing of the disposable blade may occur and be contained within the of Flexible Curette Shaft Assembly during surgery". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as design.

Recall record

Recall number: Z-1698-2024
Classification: Class II
Status: Completed
Initiated: 2023-03-14
Posted: 2024-04-29
Recalling firm: Advanced Research Medical
Product: ADVANCED RESEARCH MEDICAL Lumbar Interbody Fusion System (OLLIF), Flexible Curette Loop Blade, Part # 01-06-4; treatment of degenerative disc disease
Product code: MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Reason for recall: Potential shearing of the disposable blade may occur and be contained within the of Flexible Curette Shaft Assembly during surgery.
Root cause tag: design
FDA root cause: Device Design
Action: 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.
Quantity in commerce: 1150 units
Distribution: US Nationwide distribution in the state of Minnesota.
Product codes and lots: UDI/DI 00850014575311, Lot Numbers: 87458, BB059AA, BB140AA, BB140AB, BB307AA, BB350AA, BC061AA, BC130AA, BC130AA-2, BC274AA, BD083AA, BD083AB, BD083AC

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1698-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1698-2024	Class II	Completed	Voluntary: Firm initiated	2024-05-08	2024-04-29

Product code MAX

K173947Class IILumbar Interbody Fusion System (OLLIF)Advanced Research Medical, LLC / cleared 2018-07-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)