CERTAIN® BELLATEK® ENCODE® IEHA464Recalls & reported problems
ZimVie US Corp LLC · CERTAIN® BELLATEK® ENCODE® HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 4MM(H) · Class 2 · Implant
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00844868004684), received between Jan 4, 2021 and Dec 3, 2021 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Positioning Failure” (4 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
- Positioning Failure4
- Unintended Movement1
Patient problems
- No Information4
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 3, 2021Positioning Failure; Positioning Failure
IT WAS REPORTED THAT THE PATIENT CALLED AND STATED THAT THEIR HEALING ABUTMENT FELT WEIRD. IT WAS DISCOVERED ON THE X-RAY THAT THE HEALING ABUTMENT WAS NOT SEATED AND WAS UNABLE TO BE TORQUED DOWN FURTHER. IT WAS REMOVED AND REPLACED WITH AN ANGLED ABUTMENT, WHICH SEATED AND THE PATIENT IS CURRENTLY FINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12925819 ↗MalfunctionJan 22, 2021Positioning Failure; Positioning Failure
NO ADDITIONAL EVENT INFORMATION AT THE TIME OF THIS REPORT.
Patient problems: No Information
MAUDE report 11219178 ↗MalfunctionJan 21, 2021Positioning Failure; Positioning Failure
CUSTOMER REPORTED THAT HE TRIED HEALING ABUTMENT IN 2 DIFFERENT PATIENTS, BUT WOULD NOT SEAT. DOCTOR PLACED ONE-PIECE HEALING ABUTMENT TO COMPLETE PROCEDURE.
Patient problems: No Information
MAUDE report 11211551 ↗MalfunctionJan 21, 2021Positioning Failure; Positioning Failure
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Information
MAUDE report 11211533 ↗MalfunctionJan 4, 2021Unintended Movement; Unintended Movement
IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A LOOSE CROWN AND ABUTMENT. HEALING ABUTMENT WAS REPLACED WITH A NEW ONE. NO PATIENT IMPACT REPORTED. TOOTH #19.
Patient problems: No Information
MAUDE report 11111758 ↗
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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.