BellaTek® Encode® TEHA4503Recalls & reported problems
ZimVie US Corp LLC · TSV™ BELLATEK® ENCODE® HEALING ABUTMENT 4.5MM (D) X 5.0MM (P) X 3MM (H) · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- 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 00844868040941), received between Aug 4, 2023 and Aug 4, 2023 — 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.
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.
MalfunctionAug 4, 2023Positioning Failure; Positioning Failure
IT WAS REPORTED THAT THE ENCODE ABUTMENT WOULD NOT SEAT IN THE PATIENTS MOUTH. THEY WERE ABLE TO USE ANOTHER ABUTMENT TO COMPLETE THE CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17458878 ↗
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- Esthetic Abutment 36669Nobel Biocare AB · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS1 recall2 reports
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- 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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