APC™ II Unitek™ Gemini 3027-382Recalls & reported problems
3m Unitek Corporation · Unitek(TM) Gemini SL Bracket APC(TM) II MBT(TM) LL5 -17T/2A Hk .022 5/Pk · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00652221226273), received between Dec 11, 2017 and Dec 11, 2017 — classified as 2 injuries.
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
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Tooth Fracture2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 11, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (B)(4) 2017, 3M WAS NOTIFIED BY AN ORTHODONTIST THAT A PATIENT BROUGHT A 3M UNITEK APC II GEMINI SL BRACKET (LL5) TO THE OFFICE WHICH DEBONDED FROM TOOTH #20 WITH A PIECE OF TOOTH ENAMEL ATTACHED. THIS BRACKET WAS THE THIRD BRACKET THAT HAD BEEN BONDED TO THE SAME TOOTH; THE PREVIOUS BRACKETS HAD BEEN BONDED ON (B)(6) 2016 AND (B)(6) 2017, AND THE CURRENT BRACKET WAS BONDED (B)(6) 2017. A NON-3M BRAND PRIMER WAS USED DURING THE BONDING PROCEDURE. UPON FOLLOW-UP BY 3M, IT WAS LEARNED THAT THE ENAMEL DAMAGE WAS DOWN TO DENTIN. THE PATIENT ADMITTED TO EATING HARD PIZZA CRUST WHEN THE LL5 BRACKET CAME OFF. THE ORTHODONTIST APPLIED COMPOSITE TO FILL IN THE AFFECTED AREA OF ENAMEL AND RE-BONDED A NON-3M BRAND BRACKET. THE ORTHODONTIST PLANS TO SEND THE PATIENT TO THEIR DENTIST FOR A PERMANENT RESTORATION AT THE END OF ORTHODONTIC TREATMENT.
Patient problems: Tooth Fracture
MAUDE report 7106467 ↗InjuryDec 11, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2017, 3M WAS NOTIFIED BY AN ORTHODONTIST THAT A PATIENT BROUGHT A 3M UNITEK APC II GEMINI SL BRACKET (LL5) TO THE OFFICE WHICH DEBONDED FROM TOOTH #20 WITH A PIECE OF TOOTH ENAMEL ATTACHED. THIS BRACKET WAS THE SECOND BRACKET THAT HAD BEEN BONDED TO THE SAME TOOTH; THE PREVIOUS BRACKET HAD BEEN BONDED ON (B)(6) 2017, AND THE CURRENT BRACKET WAS BONDED (B)(6) 2017. A NON-3M BRAND PRIMER WAS USED DURING THE BONDING PROCEDURE. UPON FOLLOW-UP BY 3M, IT WAS LEARNED THAT THE ENAMEL DAMAGE WAS DOWN TO DENTIN. THE PATIENT ADMITTED TO EATING HALLOWEEN CANDY WHEN THE BRACKET CAME OFF. THE ORTHODONTIST APPLIED COMPOSITE TO FILL IN THE AFFECTED AREA OF ENAMEL AND RE-BONDED A NON-3M BRAND BRACKET. THE ORTHODONTIST PLANS TO SEND THE PATIENT TO THEIR DENTIST FOR A PERMANENT RESTORATION AT THE END OF ORTHODONTIC TREATMENT.
Patient problems: Tooth Fracture
MAUDE report 7106464 ↗
Other ADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN devices
- APC™ Flash-Free Victory Series™ Superior Fit 4069-51143m Unitek Corporation · ADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN1 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.
How reports and recalls are matched · Editorial policy · Report an error on this page