Aligner, Sequential
FDA adverse event reports and recall history for aligner, sequential (product code NXC), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 18,440
- Deaths
- 1
- Injuries
- 15,748
- Malfunctions
- 2,595
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2024-12-23Open, ClassifiedSoftware design (manufacturing process)
Clarity Precision Grip Attachments, for use in orthodontic treatment. Part numbers/SKUs: 359-830 359-831 359-832 359-833 359-834 359-835 359-836 359-837
Attachments may not mate with the tooth as intended in the digital treatment design.
- 2024-12-23Open, ClassifiedDevice Design
BYTE Aligner System REF PRS-0063 BYTE All-Day Aligner System BYTE AT-Night Aligner System A custom-made orthodontic appliance, typically supplied in series intended to be worn in succession and self-changed every few weeks, designed to influence the shape and/or function of the stomatognathic system to correct malocclusions.
Virtual-only clinical workflow utilized for dental aligners and impression to approve patients for aligner devices may not be suitable for patients who have certain contraindications.
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