CERTAIN® BELLATEK® ENCODE® IEHA564Recalls & reported problems
ZimVie US Corp LLC · CERTAIN® BELLATEK® ENCODE® HEALING ABUTMENT 5MM(D) X 6MM(P) X 4MM(H) · Class 2 · Implant
All models of CERTAIN BELLATEK ENCODE (31)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00844868004806), received between Jan 18, 2022 and Aug 14, 2023 — classified as 1 injury, 3 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Positioning Failure4
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryAug 14, 2023Positioning Failure; Positioning Failure
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17539865 ↗MalfunctionAug 8, 2022Positioning Failure; Positioning Failure
IT WAS REPORTED THAT THE ABUTMENT WAS NOT ABLE TO BE SEATED ON THE IMPLANT. WE WERE ABLE TO PLACE ANOTHER HEALING ABUTMENT THE SAME SIZE THAT DAY WHICH WORKED FINE. TOOTH 31.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15189409 ↗MalfunctionJan 18, 2022Positioning Failure; Positioning Failure
IT WAS REPORTED THAT THE HEALING ABUTMENTS WOULD NOT SEAT IN THE PATIENT'S MOUTH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13279267 ↗MalfunctionJan 18, 2022Positioning Failure; Positioning Failure
IT WAS REPORTED THAT THE HEALING ABUTMENTS WOULD NOT SEAT IN THE PATIENT'S MOUTH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13279139 ↗
Other ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS devices
- CERTAIN® GOLD-TITE® IUNIHGZimVie US Corp LLC · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS151 reports
- Nobel Biocare® 36662Nobel Biocare AB · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS2 recalls5 reports
- 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
- Straumann Anatomic Healing Abutments XC (AHA) Healing ComponentsInstitut 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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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