TSV® BELLATEK® ENCODE® TEEHA445Recalls & reported problems
ZimVie US Corp LLC · TSV® BELLATEK® ENCODE® EMERGENCE HEALING ABUTMENT 4.5MM(D) 4.5MM(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 00844868045823), received between Mar 11, 2026 and Mar 11, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Unintended Movement” (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
- Unintended Movement1
Patient problems
- Inflammation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 11, 2026Unintended Movement
IT WAS REPORTED THAT PATIENT SUFFERED FROM INFLAMMATION AND DISOCCLUSION OF THE HEALING ABUTMENT FOR 1 MONTH AFTER PLACEMENT. 27 FEB 2026 CLARIFICATION: DOCTOR INDICATED THAT DISOCCLUSION MEANING LOOSENING OF THE ABUTMENT.
Patient problems: Inflammation
MAUDE report 24574192 ↗
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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.