CERTAIN® BELLATEK® ENCODE® IEEHA345Recalls & reported problems
ZimVie US Corp LLC · CERTAIN® BELLATEK® ENCODE® EMERGENCE HEALING ABUTMENT 3.4MM(D) 3.8MM(P) 5MM(H) · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00844868045403), received between May 4, 2023 and Feb 3, 2025 — classified as 2 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Separation Failure” (2 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.
Reports received per month
Most reported problems
Device problems
- Separation Failure2
- Fracture1
- Positioning Failure1
- Separation Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Inflammation1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryFeb 3, 2025Separation Failure; Separation Failure
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: Inflammation
MAUDE report 21297841 ↗MalfunctionSep 27, 2024Positioning Failure; Positioning Failure
DOCTOR REPORTED THAT THE ENCODE ABUTMENT DOES NOT SEAT INTO THE IMPLANT. PROCEDURE COMPLETED WITH OTHER ENCODE ABUTMENT. TOOTH LOCATION 16.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20320261 ↗InjurySep 23, 2024Fracture; Fracture
IT WAS REPORTED BROKEN SCREW IN IMPLANT. UPON RESTORATION OF PERMANENT CROWN INTERNAL SCREW BROKEN OFF INTO IMPLANT. UNABLE TO REMOVE, BONE GRAFT. TOOTH #13 (UNIVERSAL).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20278585 ↗MalfunctionMay 4, 2023Separation Failure; Separation Problem; Separation Failure; Separation Problem
IT WAS REPORTED THAT CLINICIAN PLACED THE ENCODE INTO THE IMPLANT, IT GOT STUCK BUT THE DOCTOR WAS ABLE TO RETRIEVE IT. TOOTH #29.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16872631 ↗
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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