FDA Medical Device Recalls (openFDA)
Advanced Research Medical, LLC: ADVANCED RESEARCH MEDICAL Lumbar Interbody Fusion System (OLLIF), Flexible Curette Loop Blade, Part # 01-06-4; treatment of degenerative disc disease
- Recall number
- Z-1698-2024
- Recalling firm
- Advanced Research Medical, LLC
- Product
- ADVANCED RESEARCH MEDICAL Lumbar Interbody Fusion System (OLLIF), Flexible Curette Loop Blade, Part # 01-06-4; treatment of degenerative disc disease
- Status
- Completed
- Initiated
- 2023-03-14
- Posted
- 2024-04-29
- Terminated
- not on file
- Reason
- Potential shearing of the disposable blade may occur and be contained within the of Flexible Curette Shaft Assembly during surgery.
- 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
- 1150 units
- Distribution
- US Nationwide distribution in the state of Minnesota.
- Lot, serial or model codes
- UDI/DI 00850014575311, Lot Numbers: 87458, BB059AA, BB140AA, BB140AB, BB307AA, BB350AA, BC061AA, BC130AA, BC130AA-2, BC274AA, BD083AA, BD083AB, BD083AC
- 510(k) numbers
- ["K173947"]
- PMA numbers
- not on file
- Product code
- MAX
- Firm FEI
- 3016002322
- Firm city
- Burnsville
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28