CERTAIN BELLATEK ENCODERecalls & reported problems across all models
ZimVie US Corp LLC · 31 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 70
- Deaths reported
- 0
- Injuries reported
- 13
- Recalls
- 0
We found 31 models of CERTAIN BELLATEK ENCODE by ZimVie US Corp LLC in the FDA's device registry (GUDID). Together they are named in 70 adverse event reports in the FDA's MAUDE database, received between Jun 26, 2020 and Sep 25, 2026 — classified as 13 injuries, 57 malfunctions.
The most frequently reported specific device problem is “Positioning Failure” (43 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 CERTAIN BELLATEK ENCODE problems
Device problems
- Positioning Failure43
- Fracture8
- Mechanical Problem6
- Separation Failure5
- Unintended Movement5
- Separation Problem3
- Adverse Event Without Identified Device or Use Problem1
- Device Damaged by Another Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions56
- No Information6
- No Code Available2
- Pain2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Inflammation1
- Insufficient Information1
- Unspecified Infection1
CERTAIN BELLATEK ENCODE models
31 models, most reported first. Each model has its own page with its reports, recalls and device details.
- CERTAIN® BELLATEK® ENCODE® IEHA444ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS7 reports
- CERTAIN® BELLATEK® ENCODE® IEEHA455Abutment, Implant, Dental, Endosseous7 reports
- CERTAIN® BELLATEK® ENCODE® IEHA454ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS5 reports
- CERTAIN® BELLATEK® ENCODE® IEHA464ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS5 reports
- CERTAIN® BELLATEK® ENCODE® IEHA564ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS4 reports
- CERTAIN® BELLATEK® ENCODE® IEEHA345Abutment, Implant, Dental, Endosseous4 reports
- CERTAIN® BELLATEK® ENCODE® IEEHA565Abutment, Implant, Dental, Endosseous4 reports
- CERTAIN® BELLATEK® ENCODE® IEHA354ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS3 reports
- CERTAIN® BELLATEK® ENCODE® IEHA466ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS3 reports
- CERTAIN® BELLATEK® ENCODE® IEEHA563Abutment, Implant, Dental, Endosseous3 reports
- CERTAIN® BELLATEK® ENCODE® IEHA563ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS2 reports
- CERTAIN® BELLATEK® ENCODE® IEEHA353Abutment, Implant, Dental, Endosseous2 reports
- CERTAIN® BELLATEK® ENCODE® IEEHA355Abutment, Implant, Dental, Endosseous2 reports
- CERTAIN® BELLATEK® ENCODE® IEEHA443Abutment, Implant, Dental, Endosseous2 reports
- CERTAIN® BELLATEK® ENCODE® IEHA343ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS1 report
- CERTAIN® BELLATEK® ENCODE® IEHA344ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS1 report
- CERTAIN® BELLATEK® ENCODE® IEHA353ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS1 report
- CERTAIN® BELLATEK® ENCODE® IEHA356ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS1 report
- CERTAIN® BELLATEK® ENCODE® IEHA443ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS1 report
- CERTAIN® BELLATEK® ENCODE® IEHA446ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS1 report
- CERTAIN® BELLATEK® ENCODE® IEHA453ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS1 report
- CERTAIN® BELLATEK® ENCODE® IEHA553ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS1 report
- CERTAIN® BELLATEK® ENCODE® IEHA556ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS1 report
- CERTAIN® BELLATEK® ENCODE® IEHA574ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS1 report
- CERTAIN® BELLATEK® ENCODE® IEHA578ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS1 report
- CERTAIN® BELLATEK® ENCODE® IEEHA357Abutment, Implant, Dental, Endosseous1 report
- CERTAIN® BELLATEK® ENCODE® IEEHA445Abutment, Implant, Dental, Endosseous1 report
- CERTAIN® BELLATEK® ENCODE® IEEHA453Abutment, Implant, Dental, Endosseous1 report
- CERTAIN® BELLATEK® ENCODE® IEEHA467Abutment, Implant, Dental, Endosseous1 report
- CERTAIN® BELLATEK® ENCODE® IEEHA575Abutment, Implant, Dental, Endosseous1 report
- CERTAIN® BELLATEK® ENCODE® IEEHA675Abutment, Implant, Dental, Endosseous1 report
Recent CERTAIN BELLATEK ENCODE adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Positioning Failure
It was reported that during the second-stage surgery, the insertion of the Encode Emergence healing screw was impossible. The doctor was unable to screw the device. Tooth site 26.No impact on the patient reported. Procedure was completed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50896488 ↗MalfunctionMay 11, 2026Positioning Failure
IT WAS REPORTED THAT THE HEALING ABUTMENT IS NOT ENGAGING INTO THE IMPLANT AT TOOTH SITE #18. DID NOT SEAT EVEN WITH THE PROFILER. ANOTHER HEALING ABUTMENT WAS OPENED AND SEATED WITH NO PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25135365 ↗MalfunctionMay 5, 2026Unintended Movement
IT WAS REPORTED THAT THE PATIENT CAME IN FOR FOLLOW UP AND THE ABUTMENT/SCREW HAD LOOSENED ON A PREVIOUSLY RESTORED IMPLANT. CLINICAL EVIDENCE SHOWS NO EVIDENCE OF FRACTURE OF THE IMPLANT OR ABUTMENT. TOOTH SITE #28.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25086639 ↗MalfunctionApr 20, 2026Positioning Failure
IT WAS REPORTED THAT THE HEALING ABUTMENT COULD NOT BE FULLY CONNECTED TO THE IMPLANT AT TOOTH SITE #20. A HEALING ABUTMENT OF THE SAME PART NUMBER WAS CONNECTED TO COMPLETE THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24924847 ↗MalfunctionApr 17, 2026Positioning Failure
IT WAS REPORTED THAT THE HEALING ABUTMENT WAS NOT SEATING CORRECTLY ON THE IMPLANT AT TOOTH SITE #28. THE PROCEDURE WAS COMPLETED WITH ANOTHER HEALING ABUTMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24916125 ↗MalfunctionApr 3, 2026Positioning Failure
IT WAS REPORTED THAT THE ABUTMENT WAS NOT GOING ALL THE WAY DOWN THE IMPLANT. THEREFORE, NOT SEATING PROPERLY ON THE IMPLANT. USED ANOTHER ONE THAT THEY HAD ON SHELVES, AND ALL WAS FINE. PATIENT IS FINE AND ALL GOOD WAS ABLE TO COMPLETE CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24779771 ↗MalfunctionMar 31, 2026Mechanical Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24747873 ↗MalfunctionFeb 25, 2026Positioning Failure
IT WAS REPORTED THAT HA WOULD NOT FIT INTO THE IMPLANT. OPENED A BRAND NEW 4.1X4.1X5MM ENCODE HA AND IT WOULD NOT SIT INTO THE IMPLANT, THERE WAS A GAP BETWEEN THE HA AND THE IMPLANT, ATTEMPTED TO RE-SEAT AND HAD TO IMPROVEMENT, RADIOGRAPH WERE TAKEN DOCUMENTING THE PROBLEM. TOOTH SITE # 37. ADDITIONAL APPOINTMENT REQUIRED, WILL NEED TO USE A SCAN BODY. THE PROCEDURE COMPLETED USING ANOTHER HA, FIT FINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24444230 ↗MalfunctionJan 23, 2026Positioning Failure
IT WAS REPORTED THAT THE ABUTMENT AT IMPLANT SITE #29 WAS NOT SEATING RIGHT. THE PATIENT CAME BACK BECAUSE IT "DIDN'T FEEL RIGHT." THE ABUTMENT LOST INTEGRATION. THE IMPLANT REMAINED IN PLACE WITH NO KNOWN ISSUES. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24165167 ↗MalfunctionJan 6, 2026Positioning Failure
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23974484 ↗MalfunctionNov 25, 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 23646875 ↗MalfunctionNov 11, 2025Positioning Failure; Positioning Failure
IT WAS REPORTED THAT THE IMPLANT AT AN UNKNOWN TOOTH SITE HAD A HEALING ABUTMENT THAT WOULD NOT SEAT. THE PATIENT STATED THAT HER IMPLANT CROWN HAS COME LOOSE MULTIPLE TIMES AND SINCE HER DENTIST CHANGED LOCATION, SHE HAD FOUND ANOTHER DENTIST TO TRY TO SEAT THE CROWN BACK. DR. (B)(6) ATTEMPTED TO SEAT THE CROWN A COUPLE OF TIMES AND WAS UNSUCCESSFUL AND MENTIONED THAT IT COULD BE A MISTAKE FROM THE LAB. THE PATIENT WAS SENT BACK TO THE OFFICE TO REMOVE THE CROWN AND TO PLACE A NEW ENCODE HEALING ABUTMENT TO GET NEW IMPRESSIONS AND CROWN. THE NEW ENCODE WOULD NOT SEAT FULLY. THE IMPLANT WAS REMOVED AND REPLACED. IT WAS UNKNOWN WHY THE NEW ENCODE WOULD NOT SEAT FULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23529125 ↗MalfunctionOct 20, 2025Positioning Failure; Positioning Failure
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23334895 ↗MalfunctionOct 15, 2025Mechanical Problem; Mechanical Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23301137 ↗InjurySep 18, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23088003 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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