CONCORDE 287903001Recalls & reported problems
Depuy Spine, LLC · CONCORDE SYSTEM RASP, STRAIGHT BAYONETED · Class 1
All models of CONCORDE (9)
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 10705034219929), received between Mar 5, 2024 and Mar 5, 2024 — 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.
Reports received per month
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.
MalfunctionMar 5, 2024Break; Break
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN ITALY AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THERE WAS BREAKAGE. NO OTHER INFORMATION WAS PROVIDED. THERE WAS NO PATIENT IMPACT REPORTED. THIS REPORT IS FOR ONE (1) CONCORDE RASP STR BAYNT THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18836316 ↗
Other RASP, SURGICAL, GENERAL & PLASTIC SURGERY devices
- Progressive proximal rasp PIP 211-A43000Keri Medical SA · Rasp, Surgical, General & Plastic Surgery4 reports
- VG2 273340107Medos International Sàrl · RASP, SURGICAL, GENERAL & PLASTIC SURGERY2 reports
- VG2 273340106Medos International Sàrl · RASP, SURGICAL, GENERAL & PLASTIC SURGERY2 reports
- NA 698273327Depuy Spine, LLC · RASP, SURGICAL, GENERAL & PLASTIC SURGERY1 report
- VG2 273340108Medos International Sàrl · RASP, SURGICAL, GENERAL & PLASTIC SURGERY1 report
- CONCORDE 287903003Depuy Spine, LLC · RASP, SURGICAL, GENERAL & PLASTIC SURGERY1 report
- Innomed, Inc. 3004-01Innomed, Inc. · Rasp, Surgical, General & Plastic Surgery1 report
- VG2 273340109Medos International Sàrl · RASP, SURGICAL, GENERAL & PLASTIC SURGERY1 report
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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