BioHorizons PYAEARecalls & reported problems
Biohorizons Implant Systems, Inc · Internal 3.5mm Angled Esthetic Abutment · Class 2 · Implant
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00847236005740), received between Nov 25, 2025 and Jan 30, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
1 other recall cover devices cleared under the same FDA submission (K103691, 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
- Break1
- Failure to Osseointegrate1
- Fracture1
- Misconnection1
Patient problems
- Insufficient Information2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 30, 2026Break; Misconnection
THIS REPORT INDICATES TWO (2) MALFUNCTION EVENT. A REVIEW OF THE EVENT INVOLVED THE DEVICE(S) EXPERIENCING AN BROKEN ABUTMENT. NO PATIENT ADVERSE EVENT WAS REPORTED. NO INFORMATION REGARDING PATIENT DEMOGRAPHICS WERE PROVIDED.
Patient problems: Insufficient Information
MAUDE report 24226899 ↗InjuryNov 25, 2025Fracture; Failure to Osseointegrate; Fracture; Failure to Osseointegrate
Recalls under the same FDA submission
These recalls involve devices cleared under K103691, 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.