ClearCorrect System Retainer (REF REF-04)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI D865REF00041), received between Jun 7, 2021 and Oct 19, 2022 — classified as 3 injuries.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER'S OFFICE CALLED IN AND STATED THE LOWER ARCH RETAINER FOR CASE# (B)(4) IS TOO TIGHT ON THE PATIENT. UPON REMOVAL, THE LOWER RETAINER BROKE A TOOTH. TOOTH #24 WAS CHIPPED ON THE MESIAL, FACIAL, AND LINGUAL. THE PROVIDER USES AN OUTIE TOOL TO REMOVE THE RETAINER FROM THE LOWER ARCH. THE PROVIDER REPAIRED THE TOOTH IMMEDIATELY.

  Patient problems: Tooth Fracture

  MAUDE report 15635472 ↗
• InjurySep 3, 2021Biocompatibility; Biocompatibility

  CHARMAINE FROM THE CUSTOMER'S OFFICE CALLED IN STATING THE PATIENT FOR CASE # (B)(4) WORE ALL STEPS OF TREATMENT WITH NO TROUBLE, BUT CLAIMS SHE IS EXPERIENCING AN ALLERGIC REACTION TO THE RETAINERS. THE PATIENT IS CURRENTLY WEARING UPPER AND LOWER RETAINER AND APPEARS TO HAVE A PRESENCE OF SWELLING OF THE MOUTH AND LIPS WITH SOME HIVES. THE PATIENT DOES NOT HAVE ANY DIFFICULTY BREATHING, NO KNOWN ALLERGY TO PLASTIC AND DISINFECTANTS. THE PRODUCT WAS RINSED USING POLYDENT AND APPEAR TO BE CLEAN. THE PATIENT HAS SINCE TAKEN ALLERGY MEDICATION AND SEEN THEIR PRIMARY PHYSICIAN AND WAITING ON RESULTS FROM THEIR BLOOD TEST. PHOTOS HAVE BEEN INCLUDED. THE PATIENT IS PARTICULARLY CONCERNED BECAUSE WE ARE NOT GOING TO REMAKE THE RETAINERS OUT OF THE NEW MATERIAL SO THE PATIENT MIGHT NOT RETURN THEM. IT WAS ADVISED TO DISCONTINUE THE USE OF THE RETAINER UNTIL WE HAVE MORE INFORMATION.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 12423335 ↗
• InjuryJun 7, 2021Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  CANDID COMPLAINT MANAGEMENT REPORTED: THE PATIENT FOR CASE (B)(4) REPORTS CUTS, IRRITATION TO THE GUMS, AND INFECTION FROM THE EDGES OF THEIR RETAINER. THE PATIENT REPORTS THAT THEY HAD TO VISIT A DOCTOR DUE TO INFECTION FROM THE DAMAGE FROM THE RETAINER. WHEN ASKED WHERE THE ALIGNERS WERE ROUGH THE PATIENT REPORTS "ALL OVER." THE PATIENT REPORTED PAIN AND SWELLING IN HIS FACE FIRST ON (B)(6) 2021 TO CANDID; THE COMPLAINT WAS NOT REPORTED TO CANDID QUALITY UNTIL 05/03/2021. THE PATIENT REPORTED NO ISSUES WITH THE TREATMENT ALIGNERS. THE PATIENT REPORTED SYMPTOMS OF BLEEDING, SWELLING, AND PAIN IN THE LEFT SIDE OF HIS FACE. ADDITIONALLY, WE'VE (CANDID) FOUND OUT THAT THE PATIENT HAS NOT HAD A DENTAL CLEANING SINCE (B)(6) 2000. THE PHOTOS AND THIS INFORMATION WERE SENT TO THE PATIENT'S ORTHODONTIST, AND THE ORTHODONTIST ADVISED THAT THE PATIENT WAS HAVING GINGIVAL INFLAMMATION AND NEEDED TO SEE A DENTIST FOR A CLEANING AND EXAM. AT THIS TIME, THE ORTHODONTIST ADVISED THAT THE PATIENT MAY BENEFIT FROM PERFORMING A HORIZONTAL TRIM ON THE RETAINER. CLINICAL NOTES FROM THE PATIENT'S VISIT TO URGENT CARE WERE REQUESTED BUT HAVE NOT BEEN PROVIDED BY THE PATIENT.

  Patient problems: Subclinical Infection

  MAUDE report 11952222 ↗