ClearCorrect System Retainer (REF REF04)Recalls & reported problems
Clearcorrect Operating, LLC · The ClearCorrect retainer device is fabricated of clear thin thermoformed polyurethane plastic and functions to hold the teeth in their new positions after orthodontic tooth movement is achieved. During this phase of treatment, the fundamental function of the appliance is to maintain tooth position rather than provided continuous force application. · Class 1
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI D865REF04001), received between Feb 10, 2025 and Aug 4, 2025 — classified as 3 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information3
- Patient Device Interaction Problem3
Patient problems
- Sensitivity of Teeth1
- Subclinical Infection1
- Tooth Fracture1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryAug 4, 2025Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem
WE RECEIVED THE NEW RETAINER WHICH UNFORTUNATELY THE SAME AS THE PREVIOUS ONE!! EXTREMELY TIGHT AND WHEN THE PATIENT TRIED IT, SHE ENDED UP CHIPPING HER LOWER INCISOR!!!! AND HER LOWER TEETH ARE ALL VERY SORE! IT IS VERY TIGHT AND WE STRUGGLED TO PUT IT ON OR TAKE IT OUT!!
Patient problems: Tooth Fracture
MAUDE report 22699913 ↗InjuryJun 10, 2025Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem
PATIENT CALLED TO REPORT IT, SHE HAD AN ALLERGIC REACTION TO THE RETAINER. SHE HAS THE ALLERGIC IN THE THROAT AND THE TONGUE. SHE WANTED TO KNOW THE MATERIALS THE RETAINERS ARE MADE.
Patient problems: Subclinical Infection
MAUDE report 22178064 ↗InjuryFeb 10, 2025Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem
THE UPPER RETAINER IS TOO TIGHT, IT WAS TOO TIGHT THAT IT RIPPED OUT A FILLING IN MY TOOTH #9.
Patient problems: Sensitivity of Teeth
MAUDE report 21350102 ↗
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- IPS 60-500-01-09KLS-Martin L.P. · POSITIONER, TOOTH, PREFORMED2 reports
- Essix A+ 10045Dentsply Sirona Orthodontics Inc. · POSITIONER, TOOTH, PREFORMED1 report
- Herbst Bite Jumper 3000-0010Allesee Aoa-Pro · POSITIONER, TOOTH, PREFORMED1 report
- Distal Jet 3000-0090Allesee Aoa-Pro · POSITIONER, TOOTH, PREFORMED1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.