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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Advanced Research Medical, LLC: Lumbar Interbody Fusion System Flexible Curette Blade Recalled for Shearing Risk

Agency Publication Date: April 29, 2024
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Summary

Advanced Research Medical is recalling 1,150 units of the Lumbar Interbody Fusion System (OLLIF) Flexible Curette Loop Blade (Part # 01-06-4) used for treating degenerative disc disease. This recall was initiated because the disposable blade may shear or break off during surgery, potentially leaving metal fragments inside the patient's body within the shaft assembly. These devices were distributed across Minnesota between March 2023 and May 2024. Patients should contact their healthcare provider if they have concerns about a procedure involving this equipment.

Risk

The disposable loop blade can potentially break or shear off during a surgical procedure. If this occurs, the broken blade components could be left inside the patient's spine or within the surgical tool's shaft, requiring additional surgical intervention to remove the debris and posing a risk of internal injury.

What You Should Do

  1. Identify if your surgical facility has the ADVANCED RESEARCH MEDICAL Lumbar Interbody Fusion System (OLLIF), Flexible Curette Loop Blade, Part # 01-06-4 with UDI/DI 00850014575311.
  2. Check your inventory for the following affected Lot Numbers: 87458, BB059AA, BB140AA, BB140AB, BB307AA, BB350AA, BC061AA, BC130AA, BC130AA-2, BC274AA, BD083AA, BD083AB, or BD083AC.
  3. If you are a patient who has undergone a lumbar fusion surgery using this system and have concerns, contact your surgeon or healthcare provider immediately.
  4. Healthcare providers should stop using the affected lot numbers and contact Advanced Research Medical at their Burnsville, MN location for instructions on returning or replacing the equipment.
  5. For further information or to report issues, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer notification and device containment

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: ADVANCED RESEARCH MEDICAL Lumbar Interbody Fusion System (OLLIF), Flexible Curette Loop Blade, Part # 01-06-4
Model / REF:
01-06-4
UDI/DI 00850014575311
Lot Numbers:
87458
BB059AA
BB140AA
BB140AB
BB307AA
BB350AA
BC061AA
BC130AA
BC130AA-2
BC274AA
BD083AA
BD083AB
BD083AC

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94279
Status: Resolved
Manufacturer: Advanced Research Medical, LLC
Sold By: Advanced Research Medical, LLC
Manufactured In: United States
Units Affected: 1150 units
Distributed To: Minnesota

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.