BellaTek TF4121Recalls & reported problems
ZimVie US Corp LLC · TSV® BELLATEK® FLEX ABUTMENT 4.5MM (D) 12MM (H) HEXED · 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 00844868043973), received between Feb 8, 2022 and Feb 8, 2022 — 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.
Most reported problems
Device problems
- Unintended Movement1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 8, 2022Unintended Movement; Unintended Movement
IT WAS REPORTED THAT THE ABUTMENT SCREW BECAME LOOSE. THE DOCTOR RETIGHTENED IT AND THE PATIENT WAS SENT HOME.
Patient problems: Insufficient Information
MAUDE report 13482692 ↗
Other Abutment, Implant, Dental, Endosseous devices
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- 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 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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