Sycamore Wood Wedges 9061103Recalls & reported problems
Premier Dental Products Company · WEDGE BOX OF 400 - 15 · Class 1
Data updated Oct 18, 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 00348783005059), received between Feb 18, 2026 and Feb 18, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Unexpected Color” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Unexpected Color1
Patient problems
- Skin Discoloration1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 18, 2026Unexpected Color
WE RECEIVED A COMPLAINT FOR DENTAL OFFICE STATING THAT THE BLUE DYE IN WEDGE APPEARED TO STAIN A PATIENT'S GUM.
Patient problems: Skin Discoloration
MAUDE report 24384680 ↗
Other Retainer, Matrix devices
- Integra® Miltex® 72-30Integra Lifesciences Production Corporation · RETAINER, MATRIX1 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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