ALIF 273508115Recalls & reported problems

Medos International Sàrl · UNIVERSAL ALIF INSTRUMENT SET OSTEOTOME, STRAIGHT 15mm · Class 1

Data updated Oct 16, 2026 from official FDA records · Editorial policy

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 10705034190297), received between Dec 29, 2021 and Dec 29, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

Break1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

MalfunctionDec 29, 2021Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SURGEON WAS DOING AN ANTERIOR LUMBAR INTERBODY FUSION (ALIF) DUE TO AN UNKNOWN REASON. WHILE HITTING THE INSTRUMENT WITH A MALLET AS ITS INTENDED PURPOSE THE ALIF OSTEOTOME STRAIGHT 15MM BROKE. THERE WERE NO FRAGMENTS GENERATED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) UNIVERSAL ALIF INSTRUMENT SET OSTEOTOME, STRAIGHT 15MM. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13114757 ↗

Device details

UDI-DI	`10705034190297`
Brand	ALIF
Model	273508115
Company	Medos International Sàrl
Product code	HWM · OSTEOTOME
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Apr 20, 2026

Device type (GMDN): Orthopaedic osteotome

A chisel-like, one-piece manual surgical instrument designed to cut and/or shape bone by percussion during an orthopaedic procedure. It is hand-held by the operator who uses a surgical mallet or hammer to manually impart a force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp, often flat, but can be curved (concave) in design, and is typically bevelled on both sides with sloping curves. It is either entirely made of metal (e.g., high-grade stainless steel) or has a metal blade with a handle made of synthetic material (e.g., Tufnol). This is a reusable device.

Other OSTEOTOME devices

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CS-PLUS/CSL-PLUS 75002165
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NA 2002-25-000
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All OSTEOTOME 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 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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