Recall Z-1698-2024 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
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
| Date | Apr 29, 2024 (initiated Mar 14, 2023) |
| Status | Completed |
| Reason | Potential shearing of the disposable blade may occur and be contained within the of Flexible Curette Shaft Assembly during surgery. |
| Root cause | 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 |
| Quantity | 1150 units |
| Distribution | US Nationwide distribution in the state of Minnesota. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K173947 | Lumbar Interbody Fusion System (OLLIF) Advanced Research Medical, LLC, Jul 25, 2018 |