NA LINC9255Recalls & 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
- 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 10888551000222), received between Aug 11, 2020 and Aug 18, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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 16, 2026.
Most reported problems
Device problems
- Break2
Patient problems
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 18, 2020Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN ACL (ANT. CRUCIATED LIGAMENT) PROCEDURE WITH A SHAVER BLADE STERLING CUDA LARGE HUB MAGENTA AND THE ISSUE OF AN UNKNOWN PART OF THE DEVICE BROKE INSIDE OF THE PATIENT OCCURRED. DURING THE PROCEDURE WHILE UNDER GENERAL ANESTHESIA, THE SHAVER BLADE STERLING CUDA LARGE HUB MAGENTA BROKE. THE DEVICE WAS USED FOR A RIGHT KNEE ARTHROSCOPY, MEDIAL MENISCUS REPAIR AND RIGHT KNEE ACL RECONSTRUCTION, PATELLAR TENDON AUTOGRAFT. A NEW SHAVER WAS OPENED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THE ISSUE REPORTED WAS ASSESSED AS MDR REPORTABLE AS AN UNKNOWN PART OF THE DEVICE BROKE INSIDE OF THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10420286 ↗MalfunctionAug 11, 2020Break
THE STERILMED SHAVER BLADE BROKE DURING AN ORTHOPEDIC PROCEDURE. AS A RESULT, A NEW SHAVER WAS OPENED TO COMPLETE THE ORIGINAL INTENDED PROCEDURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10390171 ↗
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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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