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FDA (Device enforcement)Recalled 2023-03-14class ii

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

Hazard

Potential shearing of the disposable blade may occur and be contained within the of Flexible Curette Shaft Assembly during surgery.

Details from the source

Reason for recall: Potential shearing of the disposable blade may occur and be contained within the of Flexible Curette Shaft Assembly during surgery. Distribution: US Nationwide distribution in the state of Minnesota. Quantity: 1150 units Lot/code info: UDI/DI 00850014575311, Lot Numbers: 87458, BB059AA, BB140AA, BB140AB, BB307AA, BB350AA, BC061AA, BC130AA, BC130AA-2, BC274AA, BD083AA, BD083AB, BD083AC

UPC codes

00850014575311

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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