Carriere® SLX 3D™ 777-UR1-10Recalls & reported problems
Ortho Organizers, Inc. · Carriere® SLX 3D™ .022 UR1 +12T 5A 0O Self-Ligating Brackets · 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 00190707048402), received between Feb 17, 2022 and Feb 17, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Biocompatibility” (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.
Most reported problems
Device problems
- Biocompatibility1
Patient problems
- Foreign Body Reaction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 17, 2022Biocompatibility; Biocompatibility
AFTER A ROUND OF ROUTINE POST-MARKET BIOCOMPATIBILITY STUDIES, ORTHO ORGANIZERS BECAME AWARE THAT A SAMPLE OF SLX 3D ORTHODONTIC BRACKETS HAD FAILED CYTOTOXICITY TESTING.
Patient problems: Foreign Body Reaction
MAUDE report 13550087 ↗
Other BRACKET, METAL, ORTHODONTIC devices
- Maestro 711-299MCQOrtho Organizers, Inc. · BRACKET, METAL, ORTHODONTIC1 recall0 reports
- Maestro 711-298QOrtho Organizers, Inc. · BRACKET, METAL, ORTHODONTIC1 recall0 reports
- Maestro 711-206-10Ortho Organizers, Inc. · BRACKET, METAL, ORTHODONTIC1 recall0 reports
- Carriere 424-925CNOrtho Organizers, Inc. · BRACKET, METAL, ORTHODONTIC2 reports
- Carriere® SLX 3D™ 777-LR4-HK-10Ortho Organizers, Inc. · BRACKET, METAL, ORTHODONTIC1 report
- Carriere 425-425ROrtho Organizers, Inc. · BRACKET, METAL, ORTHODONTIC1 report
- Carriere 424-916CNOrtho Organizers, Inc. · BRACKET, METAL, ORTHODONTIC1 report
- Carriere 424-917RNOrtho Organizers, Inc. · BRACKET, METAL, ORTHODONTIC1 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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