BioHorizons TP3CMARecalls & reported problems
Biohorizons Implant Systems, Inc · 3.0mm Custom Milled Abutment · Class 2 · Implant
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00847236012137), received between Jan 31, 2023 and Apr 29, 2026 — classified as 3 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (3 reports).
1 other recall cover devices cleared under the same FDA submission (K151621, K223697); they may or may not involve this specific model.
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
- Fracture3
- No Apparent Adverse Event1
- Use of Device Problem1
Patient problems
- Insufficient Information5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 29, 2026Use of Device Problem
THIS REPORT COVERS ONE (1) MALFUNCTION EVENT. A REVIEW OF THE EVENT INVOLVED THE DEVICE(S) EXPERIENCING A FRACTURED HEX. NO PATIENT ADVERSE EVENT WAS REPORTED. NO INFORMATION REGARDING PATIENT DEMOGRAPHICS WERE PROVIDED.
Patient problems: Insufficient Information
MAUDE report 25035984 ↗InjuryOct 23, 2024Fracture; Fracture
InjuryMar 26, 2024Fracture; Fracture
InjuryFeb 24, 2024No Apparent Adverse Event; No Apparent Adverse Event
HEX FRACTURED. VULCAN COMPLAINT # (B)(4).
Patient problems: Insufficient Information
MAUDE report 18774211 ↗MalfunctionJan 31, 2023Fracture; Fracture
THIS REPORT IS A SUMMARY OF FOUR (4) MALFUNCTION EVENTS. A REVIEW OF THE EVENT(S) INVOLVED A DEVICE EXPERIENCING A BROKEN HEX. NO ADVERSE EVENT PATIENT INFORMATION WAS REPORTED. NO INFORMATION REGARDING PATIENT DEMOGRAPHICS HAVE BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 16275278 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K151621, K223697. One submission often covers many models, so check the product and lot details in each record.
- Z-1111-2025 · Dec 6, 2024 · Open, ClassifiedTemporary Titanium Abutments
Other Abutment, Implant, Dental, Endosseous devices
- CERTAIN® GOLD-TITE® IUNIHGZimVie US Corp LLC · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS151 reports
- Nobel Biocare® 36662Nobel Biocare AB · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS2 recalls5 reports
- CERTAIN® IUNIHTZimVie US Corp LLC · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS67 reports
- ATLANTIS® 35502Dentsply Ih, Inc. · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS66 reports
- ATLANTIS® 35502Dentsply Ih, Inc. · Abutment, implant, dental, endosseous54 reports
- Esthetic Abutment 36669Nobel Biocare AB · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS1 recall2 reports
- CERTAIN® BELLATEK® IEDAT5ZimVie US Corp LLC · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS1 recall1 report
- Custom Abutments Final AbutmentsInstitut Straumann AG · Abutment, implant, dental, endosseous1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.