CLASS II Device recall · Reported 8 May 2024 · FDA Enforcement Report
Lumbar Interbody Fusion System (Ollif) recalled
Advanced Research Medical is recalling Lumbar Interbody Fusion System (Ollif), Flexible Curette Loop Blade, Part # 01-06-4, distributed nationwide in the US. The recall was initiated on 14 Mar 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1698-2024
- FDA event ID
- 94279
- Recalling firm
- Advanced Research Medical, Burnsville, MN
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 14 Mar 2023
- FDA classified
- 29 Apr 2024
- Reported
- 8 May 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Spinal Implants
Timeline
| 14 Mar 2023 | Recall initiated by company | |
| 29 Apr 2024 | Classified by FDA | +412 days |
| 8 May 2024 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential shearing of the disposable blade may occur and be contained within the of Flexible Curette Shaft Assembly during surgery.
Product as listed by the FDA
ADVANCED RESEARCH MEDICAL Lumbar Interbody Fusion System (OLLIF), Flexible Curette Loop Blade, Part # 01-06-4; treatment of degenerative disc disease
Where it was distributed
US Nationwide distribution in the state of Minnesota.
Questions about this recall
Why was it recalled?
Potential shearing of the disposable blade may occur and be contained within the of Flexible Curette Shaft Assembly during surgery.
Which lots are affected?
UDI/DI 00850014575311, Lot Numbers: 87458, BB059AA, BB140AA, BB140AB, BB307AA, BB350AA, BC061AA, BC130AA, BC130AA-2, BC274AA, BD083AA, BD083AB, BD083AC
Where was it sold?
US Nationwide distribution in the state of Minnesota.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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