MORELAND 2422-31-000Recalls & reported problems

Depuy Orthopaedics, Inc. · MORELAND REV INST U OSTEOTOME 10.5mm 8 IN · Class 1

All models of MORELAND (22)

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

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295123170), received between Dec 7, 2021 and Feb 18, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (2 reports).

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.

Most reported problems

Device problems

Material Deformation2
Naturally Worn2

Patient problems

No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

MalfunctionFeb 18, 2022Material Deformation; Naturally Worn; Material Deformation; Naturally Worn
IT WAS REPORTED THAT THE OSTEOTOMES ARE BENT AND THE ENDS HAVE A ROUGH EDGE. 1 OPENED AND 2ND STILL IN PACKAGING. THESE HAVE NOT YET BEEN USED IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13559489 ↗
MalfunctionDec 7, 2021Material Deformation; Naturally Worn; Material Deformation; Naturally Worn
IT WAS REPORTED THAT THE OSTEOTOMES ARE BENT AND THE ENDS HAVE A ROUGH EDGE. 1 OPENED AND 2ND STILL IN PACKAGING. THESE HAVE NOT YET BEEN USED IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12953657 ↗

Device details

UDI-DI	`10603295123170`
Brand	MORELAND
Model	2422-31-000
Catalog no.	242231000
Company	Depuy Orthopaedics, Inc.
Product code	HWM · OSTEOTOME
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	—
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Oct 25, 2018

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

NA 2598-07-530
Depuy (Ireland) · OSTEOTOME
86 reports
NA 2002-31-000
Depuy (Ireland) · OSTEOTOME
61 reports
Watson Extraction System 17601
Depuy (Ireland) · Osteotome
60 reports
MORELAND 2422-10-000
Depuy Orthopaedics, Inc. · OSTEOTOME
53 reports
SIGMA 2024-47-111
Depuy (Ireland) · OSTEOTOME
43 reports
Watson Extraction System 17001
Depuy (Ireland) · Osteotome
41 reports
CS-PLUS/CSL-PLUS 75002165
Smith & Nephew, Inc. · OSTEOTOME
35 reports
NA 2002-25-000
Depuy (Ireland) · OSTEOTOME
31 reports

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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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