Lumbar Interbody Fusion System (OLLIF) 01-06-4Recalls & reported problems

Advanced Research Medical LLC · Lumbar Interbody Fusion System (OLLIF) Flexible Curette Loop Blade · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 0
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

Mar 14, 2023Class IICompleted
Potential shearing of the disposable blade may occur and be contained within the of Flexible Curette Shaft Assembly during surgery.
Z-1698-2024 · Root cause: Device Design · Recall details · FDA record ↗

Device details

UDI-DI	`00850014575311`
Brand	Lumbar Interbody Fusion System (OLLIF)
Model	01-06-4
Company	Advanced Research Medical LLC
Product code	MAX · Intervertebral Fusion Device With Bone Graft, Lumbar
Class	Class 2
FDA submission	K173947
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Mar 10, 2021

Device type (GMDN): Bone curette, single-use

A manual surgical instrument designed for cutting and excising bone tissue typically during an orthopaedic or a plastic surgery procedure. It is typically designed as a long, slender instrument with a handle at the proximal end and a concave, spoon-like tip which has a sharp edge, at the distal end, or it may be double-ended, and is used to facilitate the removal of the bone tissue without causing trauma to the surrounding muscles. It is typically made of high-grade stainless steel and is a common instrument of choice for the removal of the bone. This is a single-use device.

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All Intervertebral Fusion Device With Bone Graft, Lumbar devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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