CERTAIN® BELLATEK® ENCODE® IEEHA445Recalls & reported problems
ZimVie US Corp LLC · CERTAIN® BELLATEK® ENCODE® EMERGENCE HEALING ABUTMENT 4.1MM(D) 4.1MM(P) 5MM(H) · Class 2 · Implant
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00844868045465), received between Feb 25, 2026 and Feb 25, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Positioning Failure” (1 report).
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
- Positioning Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 25, 2026Positioning Failure
IT WAS REPORTED THAT HA WOULD NOT FIT INTO THE IMPLANT. OPENED A BRAND NEW 4.1X4.1X5MM ENCODE HA AND IT WOULD NOT SIT INTO THE IMPLANT, THERE WAS A GAP BETWEEN THE HA AND THE IMPLANT, ATTEMPTED TO RE-SEAT AND HAD TO IMPROVEMENT, RADIOGRAPH WERE TAKEN DOCUMENTING THE PROBLEM. TOOTH SITE # 37. ADDITIONAL APPOINTMENT REQUIRED, WILL NEED TO USE A SCAN BODY. THE PROCEDURE COMPLETED USING ANOTHER HA, FIT FINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24444230 ↗
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- 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
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.