Lumbar Interbody Fusion Curette Recalled for Potential Blade Shearing
Advanced Research Medical is recalling 1,150 units of its Lumbar Interbody Fusion System Flexible Curette Loop Blade because the disposable blade may shear during surgery, potentially leaving fragments within the shaft assembly. No injuries have been reported.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall involving a risk-of-harm product with potential surgical device malfunction. Although no injuries have been reported, the potential for blade shearing during a spinal fusion procedure represents a significant risk if the failure occurs.
Plain-English summary
Advanced Research Medical, LLC is recalling 1,150 units of its Lumbar Interbody Fusion System (OLLIF) Flexible Curette Loop Blade, Part # 01-06-4, a surgical instrument used in the treatment of degenerative disc disease.
The disposable blade may potentially shear during surgery and be contained within the Flexible Curette Shaft Assembly. Affected lot numbers include: 87458, BB059AA, BB140AA, BB140AB, BB307AA, BB350AA, BC061AA, BC130AA, BC130AA-2, BC274AA, BD083AA, BD083AB, and BD083AC.
The product was distributed nationwide. No injuries or illnesses have been reported in connection with this recall.
The recalled product
- Product
- ADVANCED RESEARCH MEDICAL Lumbar Interbody Fusion System (OLLIF), Flexible Curette Loop Blade, Part # 01-06-4; treatment of degenerative disc disease
- Manufacturer
- Advanced Research Medical, LLC
- Affected units
- 1,150
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (14)
- UDI/DI 00850014575311
- Lot Numbers: 87458
- BB059AA
- BB140AA
- BB140AB
- BB307AA
- BB350AA
- BC061AA
- BC130AA
- BC130AA-2
- BC274AA
- BD083AA
- BD083AB
- BD083AC
Distribution
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