CERTAIN® BELLATEK® ENCODE® IEHA454Recalls & reported problems
ZimVie US Corp LLC · CERTAIN® BELLATEK® ENCODE® HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 4MM(H) · Class 2 · Implant
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00844868004646), received between Feb 19, 2021 and Aug 2, 2022 — classified as 2 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Fracture” (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.
Most reported problems
Device problems
- Fracture2
- Positioning Failure2
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Insufficient Information1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryAug 2, 2022Fracture; Fracture
IT WAS REPORTED THAT THE HEALING ABUTMENT SCREW FRACTURED AT THE SITE.
Patient problems: Insufficient Information
MAUDE report 15152301 ↗MalfunctionMay 7, 2022Positioning Failure; Positioning Failure
IT WAS REPORTED THAT THE PRODUCT IS DEFECTIVE PER THE ORAL SURGEON. THE PRODUCT DID NOT FIT PROPERLY. CUSTOMER USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. NO OTHER SYMPTOMS WERE REPORTED. PATIENT WONT RETURN FOR AN ADDITIONAL APPOINTMENT. TOOTH # NOT REPORTED. .
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14321941 ↗MalfunctionMay 7, 2022Positioning Failure; Positioning Failure
IT WAS REPORTED THAT THE PRODUCT IS DEFECTIVE PER THE ORAL SURGEON. THE PRODUCT DID NOT FIT PROPERLY CUSTOMER USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. NO OTHER SYMPTOMS WERE REPORTED. PATIENT WONT RETURN FOR AN ADDITIONAL APPOINTMENT. TOOTH # NOT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14321610 ↗InjuryFeb 8, 2022Mechanical Problem; Mechanical Problem
CUSTOMER REPORTED THAT THEY WERE UNABLE TO GET THE ABUTMENT TO SEAT INTO THE IMPLANT AND THE IMPLANT WAS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13481269 ↗MalfunctionFeb 19, 2021Fracture; Fracture
NO ADDITIONAL EVENT INFORMATION AT THE TIME OF THIS REPORT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 11350826 ↗
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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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.