SABLE 1172.2124SRecalls & reported problems

Globus Medical, Inc. · SABLE Spacer, 10x26, 10-17mm, 15° · Class 2 · Implant

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889095966060), received between Mar 5, 2024 and Mar 5, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Handling Problem” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Device Handling Problem1

Patient problems

Failure of Implant1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionMar 5, 2024Device Handling Problem; Device Handling Problem
IT WAS REPORTED THAT A REVISION SURGERY WAS NEEDED TO REPLACE A SABLE CAGE THAT MIGRATED POST OPERATIVELY.
Patient problems: Failure of Implant
MAUDE report 18837874 ↗

Device details

UDI-DI	`00889095966060`
Brand	SABLE
Model	1172.2124S
Company	Globus Medical, Inc.
Product code	MAX · Intervertebral fusion device with bone graft, lumbar
Class	Class 2
FDA submission	K192115
Implant	Yes
Rx / OTC	—
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jul 14, 2025

Device type (GMDN): Metallic spinal interbody fusion cage

A device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is typically in the form of a hollow, porous, threaded and/or fenestrated cylindrical, or disc-shaped device made of metal [e.g., titanium (Ti)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be packaged with the cage.

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All Intervertebral fusion device with bone graft, lumbar devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.