CERTAIN® IUNAB2TRecalls & reported problems
ZimVie US Corp LLC · CERTAIN® UCLA CASTABLE NON-HEXED CYLINDER 4.1MM(D) W/LARGE DIA. TI SCREW · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00844868008521), received between Feb 26, 2021 and Jan 20, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Fracture” (3 reports).
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
Device problems
- Fracture3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 20, 2023Fracture; Fracture
IT WAS REPORTED THAT SCREW AT TOOTH SITE 45 FRACTURED AT THE THREADS OF THE SCREW AND WAS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16217953 ↗MalfunctionFeb 26, 2021Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11384688 ↗MalfunctionFeb 26, 2021Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11384629 ↗
Other ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS devices
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- 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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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