TSV BELLATEK ENCODERecalls & reported problems across all models
ZimVie US Corp LLC · 12 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 35
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls
- 0
We found 12 models of TSV BELLATEK ENCODE by ZimVie US Corp LLC in the FDA's device registry (GUDID). Together they are named in 35 adverse event reports in the FDA's MAUDE database, received between Apr 21, 2023 and May 11, 2026 — classified as 8 injuries, 27 malfunctions.
The most frequently reported specific device problem is “Positioning Failure” (14 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported TSV BELLATEK ENCODE problems
Device problems
- Positioning Failure14
- Device Damaged by Another Device4
- Mechanical Problem4
- Fracture3
- Separation Failure3
- Separation Problem3
- Use of Device Problem2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions34
- Inflammation1
TSV BELLATEK ENCODE models
12 models, most reported first. Each model has its own page with its reports, recalls and device details.
- TSV® BELLATEK® ENCODE® TEEHA355Abutment, Implant, Dental, Endosseous12 reports
- TSV® BELLATEK® ENCODE® TEEHA455Abutment, Implant, Dental, Endosseous4 reports
- TSV® BELLATEK® ENCODE® TEEHA335Abutment, Implant, Dental, Endosseous3 reports
- TSV® BELLATEK® ENCODE® TEEHA357Abutment, Implant, Dental, Endosseous3 reports
- TSV® BELLATEK® ENCODE® TEEHA365Abutment, Implant, Dental, Endosseous3 reports
- TSV® BELLATEK® ENCODE® TEEHA333Abutment, Implant, Dental, Endosseous2 reports
- TSV® BELLATEK® ENCODE® TEEHA453Abutment, Implant, Dental, Endosseous2 reports
- TSV® BELLATEK® ENCODE® TEEHA565Abutment, Implant, Dental, Endosseous2 reports
- TSV® BELLATEK® ENCODE® TEEHA445Abutment, Implant, Dental, Endosseous1 report
- TSV® BELLATEK® ENCODE® TEEHA465Abutment, Implant, Dental, Endosseous1 report
- TSV® BELLATEK® ENCODE® TEEHA467Abutment, Implant, Dental, Endosseous1 report
- TSV® BELLATEK® ENCODE® TEEHA553Abutment, Implant, Dental, Endosseous1 report
Recent TSV BELLATEK ENCODE adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMay 11, 2026Positioning Failure
IT WAS REPORTED THAT THE HEALING ABUTMENT WAS IMPOSSIBLE TO PLACE. ANOTHER HEALING ABUTMENT USED WITHOUT PROBLEMS. IMPLANT HAD BEEN PLACED (B)(6) 2025 AT TOOTH SITE 46.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25134675 ↗MalfunctionApr 20, 2026Separation Problem
IT WAS REPORTED THAT WHEN WE PUT THE HEALING ABUTMENT IN THE DR. DIDN'T LIKE THE POSITION OF THE IMPLANT SO WE DECIDED TO TAKE THE ABUTMENT OUT AND THE IMPLANT CAME WITH IT. SO THEY GOT STUCK TOGETHER. WE HAD TO PLACE ANOTHER IMPLANT DUE TO THE HEALING ABUTMENT AND IMPLANT STICKING TOGETHER. HAD TO TAKE THE IMPLANT AND ABUTMENT OUT AND PUT A NEW IMPLANT AND ABUTMENT IN. SO IT ADDED MORE TIME ON TO THE APPOINTMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24925051 ↗MalfunctionMar 13, 2026Fracture
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #14 HAD A FRACTURED SCREW THAT NEEDED TO BE REMOVED. THE IMPLANT WAS IN THE PATIENT'S MOUTH WITHOUT ANY ISSUES. AN ADDITIONAL APPOINTMENT WAS REQUIRED TO REMOVE THE FRACTURED SCREW AND REPLACE IT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24593658 ↗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 ↗MalfunctionMar 9, 2026Device Damaged by Another Device
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24551893 ↗MalfunctionMar 9, 2026Device Damaged by Another Device
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24551648 ↗MalfunctionMar 9, 2026Device Damaged by Another Device
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24551520 ↗MalfunctionFeb 5, 2026Mechanical Problem
IT WAS REPORTED THAT THE SCREW OF THE IMPLANT AT TOOTH SITE #2 BECAME CROSS-THREADED AND WAS DAMAGED. ANOTHER ENCODE WAS USED TO COMPLETE THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24267975 ↗MalfunctionDec 12, 2025Mechanical Problem; Mechanical Problem
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23794488 ↗MalfunctionDec 4, 2025Use of Device Problem; Use of Device Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23713722 ↗MalfunctionDec 4, 2025Use of Device Problem; Use of Device Problem
THE DOCTOR REPORTED THAT THE TWO ABUTMENTS DO NOT SEAT PROPERLY. NO IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23713693 ↗InjuryNov 4, 2025Separation Failure; Separation Failure
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23466028 ↗MalfunctionOct 20, 2025Fracture; Fracture
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23342473 ↗MalfunctionJun 23, 2025Positioning Failure; Positioning Failure
IT WAS REPORTED THAT THE HEALING ABUTMENT WAS PLACED ON THE IMPLANT AT TOOTH SITE #14 BUT COULD NOT BE SEATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22309449 ↗MalfunctionJun 13, 2025Positioning Failure; Positioning Failure
IT WAS REPORTED THAT THE HEALING ABUTMENT DID NOT FIT ON THE IMPLANT AT TOOTH SITE #14. A DIFFERENT SIZE ABUTMENT WAS USED TO COMPLETE THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22206327 ↗
Other ZimVie US Corp LLC products
- Tapered Screw-Vent131 models · 13,236 reports · 4 recalls
- OSSEOTITE CERTAIN74 models · 1,891 reports · 1 recall
- TSX Implants28 models · 1,279 reports
- OSSEOTITE73 models · 894 reports
- 3i T3 DCD73 models · 789 reports
- OSSEOTITE CERTAIN PREVAIL15 models · 785 reports
- CERTAIN BELLATEK12 models · 9 reports · 10 recalls
- Eztetic15 models · 382 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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