NA LINC9254Recalls & reported problems
Sterilmed, Inc. · SHAVER BLADE STERLING CUDA LARGE HUB MAGENTA · Class 2
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 10888551000215), received between Nov 1, 2018 and Nov 1, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Disintegration” (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
- Material Disintegration1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 1, 2018Material Disintegration
IT WAS REPORTED THAT A (B)(6) YEAR OLD MALE PATIENT UNDERWENT A SHOULDER ARTHROPLASTY PERFORMED WITH A STERLIMED SHAVER "SHAVER BLADE STERLING CUDA LARGE HUB MAGENTA" AND METAL SHAVINGS WERE OBSERVED DURING THE PROCEDURE. IT WAS UNKNOWN WHAT INTERVENTION WAS PERFORMED. THE DEVICE WAS EXCHANGED AND THE PROCEDURE WAS CONTINUED. THE ISSUE WITH THE METAL SHAVINGS OBSERVED DURING THE PROCEDURE WAS ASSESSED AS REPORTABLE.
Patient problems: Foreign Body In Patient
MAUDE report 8028310 ↗
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- FMS VUE II 284004Medos International Sàrl · Arthroscope562 reports
- VAPR COOLPULSE 228146Depuy Mitek, LLC · ARTHROSCOPE474 reports
- FMS DUO 284580Depuy Mitek, LLC · ARTHROSCOPE458 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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