MORELAND 2422-41-000Recalls & reported problems
Depuy Orthopaedics, Inc. · MORELAND REV INST THIN OSTEOTOME 6mm 1.5 IN · Class 1
All models of MORELAND (22)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295123231), received between Dec 8, 2020 and Dec 10, 2024 — classified as 4 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.
Reports received per month
Most reported problems
Device problems
- Material Deformation2
- Break1
- Failure to Cut1
- Naturally Worn1
- Scratched Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 10, 2024Scratched Material; Scratched Material
IT WAS REPORTED THAT THE OSTEOTOMES WERE COMPLETELY DAMAGED BEFORE THE OPERATION. NO FURTHER INFORMATION IS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20888837 ↗MalfunctionJun 24, 2024Break; Failure to Cut; Break; Failure to Cut
IT WAS REPORTED THAT THE OSTEOTOMES WERE NOT FUNCTIONING AND THEY NEED TO BE REPLACED. NO PATIENT AFFECTED, NO SURGERY DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19601827 ↗MalfunctionSep 28, 2021Material Deformation; Naturally Worn; Material Deformation; Naturally Worn
THESE ITEMS ARE BENT AND NEED REPLACING THROUGH WEAR & TEAR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12541150 ↗MalfunctionDec 8, 2020Material Deformation; Material Deformation
THE INSTRUMENTS ARE DAMAGED. THESE OSTEOTOME BLADES ARE USED ONLY FOR REVISION SURGERY, SINCE RECEIVING THE ITEMS AND COVID RESTRICTIONS, USE OF THESE INSTRUMENTS HAVE BEEN AT LEAST TWICE SINCE PURCHASE. AFTER DECONTAMINATION OF THE INSTRUMENTS, A NOTICEABLE CHANGE IN THE BLADES HAVE BEEN REPORTED BY THE HOSPITAL. THE BLADES ARE BENT AND APPEAR UNUSABLE. THIS KIT HAS SINCE BEEN QUARANTINED AND A REQUEST FROM THE HOSPITAL FOR US TO PLEASE REVIEW AND REPLACE AS THESE ITEMS ARE FAIRLY NEW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10970068 ↗
Other OSTEOTOME devices
- NA 2598-07-530Depuy (Ireland) · OSTEOTOME86 reports
- NA 2002-31-000Depuy (Ireland) · OSTEOTOME61 reports
- Watson Extraction System 17601Depuy (Ireland) · Osteotome60 reports
- MORELAND 2422-10-000Depuy Orthopaedics, Inc. · OSTEOTOME53 reports
- SIGMA 2024-47-111Depuy (Ireland) · OSTEOTOME43 reports
- Watson Extraction System 17001Depuy (Ireland) · Osteotome41 reports
- CS-PLUS/CSL-PLUS 75002165Smith & Nephew, Inc. · OSTEOTOME35 reports
- NA 2002-25-000Depuy (Ireland) · OSTEOTOME31 reports
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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