METRx® System 9560431Recalls & reported problems
Medtronic Sofamor Danek, Inc. · INSTRUMENT 9560431 METRX DILATOR 22 8MM · Class 1
All models of METRx System (5)
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 00721902458583), received between Apr 16, 2024 and Apr 16, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Discolored” (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
- Material Discolored1
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.
MalfunctionApr 16, 2024Material Discolored; Material Discolored
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PRODUCT IDENTIFIED DURING AN E VENT. IT WAS REPORTED THAT EACH DILATOR HAD A BROWN, RUST LIKE, RESIDUE THAT WAS LEFT ON THE SWAB. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19114456 ↗
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- NA 228302Medos International Sàrl · ACCESSORIES,ARTHROSCOPIC287 reports
- FIRSTPASS 72290128Smith & Nephew, Inc. · ACCESSORIES,ARTHROSCOPIC232 reports
- NA 251723Medos International Sàrl · ACCESSORIES,ARTHROSCOPIC145 reports
- COBRA 3910900093Stryker Corporation · Accessories, arthroscopic138 reports
- FirstPass 72290129Smith & Nephew, Inc. · Accessories, arthroscopic82 reports
- FirstPass 72290130Smith & Nephew, Inc. · Accessories, arthroscopic80 reports
- MITEK 242025Medos International Sàrl · ACCESSORIES,ARTHROSCOPIC61 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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