Reported May 8, 2024 · Completed
ADVANCED RESEARCH MEDICAL Lumbar Interbody Fusion System (OLLIF), Flexible Curette Loop Blade, Part # 01-06-4;…
Advanced Research Medical, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Advanced Research Medical, LLC · 1515 Highway 13 E · Burnsville, MN · 55337-2917
Is this the product you have?
- ADVANCED RESEARCH MEDICAL Lumbar Interbody Fusion System (OLLIF), Flexible Curette Loop Blade, Part # 01-06-4; treatment of degenerative disc disease
- Lot codes and dates
- UDI/DI 00850014575311
- Lot Numbers
87458BB059AABB140AABB140ABBB307AABB350AABC061AABC130AABC130AA-2BC274AABD083AABD083ABBD083AC
- Amount recalled
- 1150 units
Where it was sold
- Nationwide
- MN
Why it was recalled
Potential shearing of the disposable blade may occur and be contained within the of Flexible Curette Shaft Assembly during surgery.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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