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U.S. Department of Health and Human Services

Class 2 Device Recall Arrow Lumbar Interbody Fusion System (OLLIF)

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  Class 2 Device Recall Arrow Lumbar Interbody Fusion System (OLLIF) see related information
Date Initiated by Firm March 14, 2023
Date Posted April 29, 2024
Recall Status1 Open3, Classified
Recall Number Z-1698-2024
Recall Event ID 94279
510(K)Number K173947  
Product Classification Intervertebral fusion device with bone graft, lumbar - Product Code MAX
Product ADVANCED RESEARCH MEDICAL Lumbar Interbody Fusion System (OLLIF), Flexible Curette Loop Blade, Part # 01-06-4; treatment of degenerative disc disease
Code Information UDI/DI 00850014575311, Lot Numbers: 87458, BB059AA, BB140AA, BB140AB, BB307AA, BB350AA, BC061AA, BC130AA, BC130AA-2, BC274AA, BD083AA, BD083AB, BD083AC
Recalling Firm/
Manufacturer		 Advanced Research Medical, LLC
1515 Highway 13 E
Burnsville MN 55337-2917
For Additional Information Contact Jeffrey Langfield
651-307-9877
Manufacturer Reason
for Recall		 Potential shearing of the disposable blade may occur and be contained within the of Flexible Curette Shaft Assembly during surgery.
FDA Determined
Cause 2		 Device Design
Action The sole distributor was notified by emailed letter of updates to the Surgical Technique Guide and IFU on 14 March 2023. The IFU has been updated to address a few small details including the direct listing of single use disposable components and the definition of single use being for one level only. The surgical technique guide has improved graphics, more thorough descriptions for some of the instrument assembly steps that your scrub techs may find useful and a statement regarding the appropriate use of the Flexible Curette Blade to prevent surgeons from using it in a way that may overstress the blade and cause a break. This information was shared with the surgeons through the sole distributor.
Quantity in Commerce 1150 units
Distribution US Nationwide distribution in the state of Minnesota.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = MAX and Original Applicant = Advanced Research Medical, LLC
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