Transbond PlusRecalls & reported problems across all models

We found 2 models of Transbond Plus by 3m Unitek Corporation in the FDA's device registry (GUDID). Together they are named in 4 adverse event reports in the FDA's MAUDE database, received between Nov 22, 2017 and Jun 22, 2018 — classified as 4 injuries.

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Transbond Plus recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Nov 26, 2024Open, Classified

   Due to an increase of complaints for bracket bond failures and skin irritation or blistering.

   Z-0797-2025 · Root cause: Process control · names 2 of these models · Recall details · FDA record ↗

Most reported Transbond Plus problems

Transbond Plus models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Transbond™ Plus 712-090

  AGENT, TOOTH BONDING, RESIN
  1 recall4 reports
• Transbond™ Plus 712-091

  AGENT, TOOTH BONDING, RESIN
  1 recall0 reports

Recent Transbond Plus adverse event reports

The 4 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryJun 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, 3M WAS NOTIFIED THAT A FEMALE PATIENT, APPROXIMATELY (B)(6), HAD A LARGE BUCCAL FILLING BREAK OFF FROM A PREVIOUSLY RESTORED UPPER PRE-MOLAR TOOTH UPON DEBONDING OF A 3M APC II CLARITY ADVANCED CERAMIC BRACKET. THE BREAK WAS REPORTED TO BE DOWN TO DENTIN. THE BRACKET HAD BEEN IN PLACE FOR APPROXIMATELY 18 MONTHS. THE ORTHODONTIST REPORTED THAT THE LARGE FILLING/RESTORATION ON THE TOOTH DID NOT LOOK NORMAL. OTHER PRODUCTS USED WHEN THE BRACKET WAS INITIALLY BONDED INCLUDED A NON-3M BRAND ETCHANT. IN ADDITION, ALTHOUGH THE BRAND OF THE PRIMER OR CATALOG NUMBER WAS NOT DISCLOSED BY THE REPORTING FACILITY, BASED UPON A DESCRIPTION OF THE PRODUCT AND SALES HISTORY, IT IS SUSPECTED THAT 3M TRANSBOND PLUS SELF ETCHING PRIMER WAS ALSO POTENTIALLY USED.

  Patient problems: Tooth Fracture

  MAUDE report 7631099 ↗
• InjuryJun 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, 3M WAS NOTIFIED THAT A MALE PATIENT, APPROXIMATELY (B)(6), HAD A LARGE BUCCAL FILLING BREAK OFF FROM A PREVIOUSLY RESTORED UPPER PRE-MOLAR TOOTH OF A 3M APC II CLARITY ADVANCED CERAMIC BRACKET. THE BREAK WAS REPORTED TO BE DOWN TO DENTIN. THE BRACKET HAD BEEN IN PLACE FOR APPROXIMATELY 18 MONTHS. THE ORTHODONTIST REPORTED THAT THE LARGE FILLING/RESTORATION ON THE TOOTH DID NOT LOOK NORMAL. OTHER PRODUCTS USED WHEN THE BRACKET WAS INITIALLY BONDED INCLUDED A NON-3M BRAND ETCHANT. IN ADDITION, ALTHOUGH THE BRAND OF THE PRIMER OR CATALOG NUMBER WAS NOT DISCLOSED BY THE REPORTING FACILITY, BASED UPON A DESCRIPTION OF THE PRODUCT AND SALES HISTORY, IT IS SUSPECTED THAT 3M TRANSBOND PLUS SELF ETCHING PRIMER WAS ALSO POTENTIALLY USED.

  Patient problems: Tooth Fracture

  MAUDE report 7631090 ↗
• InjuryDec 20, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017, 3M WAS NOTIFIED THAT A (B)(6) MALE PATIENT HAD A 3M UNITEK APC FLASH-FREE CLARITY ADVANCED UPPER LEFT BICUSPID BRACKET (UL5) DEBOND FROM TOOTH #13 WHILE EATING AN APPLE. THE DEBONDED BRACKET CONTAINED TOOTH ENAMEL. THE ORTHODONTIST REMOVED THE BRACKET THAT WAS STILL ATTACHED TO THE ARCHWIRE AND SENT THE PATIENT TO HIS DENTIST FOR RESTORATION OF THE ENAMEL. UPON 3M FOLLOW-UP WITH THE ORTHODONTIST, ENAMEL DAMAGE DOWN TO DENTIN WAS REPORTED. THE BRACKET WAS INITIALLY PLACED ON (B)(6) 2016. OTHER PRODUCTS USED WHEN THE BRACKET WAS PLACED INCLUDED A NON-3M ETCHANT AND 3M UNITEK TRANSBOND PLUS SELF-ETCHING PRIMER.

  Patient problems: Tooth Fracture

  MAUDE report 7134792 ↗
• InjuryNov 22, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON OCTOBER 27, 2017, 3M WAS NOTIFIED BY AN ORTHODONTIST THAT THE TOP LAYER OF ENAMEL BROKE OFF A (B)(6) MALE PATIENT'S TOOTH (#3) UPON DEBONDING OF A 3M UNITEK APC FLASH FREE VICTORY SERIES FIT BUCCAL TUBE. 3M UNITEK TRANSBOND PLUS SELF-ETCHING PRIMER WAS USED TO PLACE THE BRACKET. THE ORTHODONTIST SENT THE PATIENT TO THEIR DENTIST TO HAVE THE TOOTH REPAIRED. UPON FOLLOW-UP BY 3M WITH THE ORTHODONTIST, IT WAS LEARNED THAT THE ENAMEL DAMAGE WAS DOWN TO DENTIN AND THE ORTHODONTIST REPORTED THAT THE TOOTH APPEARED TO BE NORMAL PRIOR TO THIS EVENT.

  Patient problems: Tooth Fracture

  MAUDE report 7054444 ↗

Other 3m Unitek Corporation products

• 3M Clarity9 models · 1 reports · 1 recall