CERTAIN BELLATEKRecalls & 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
- 9
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 10
We found 12 models of CERTAIN BELLATEK by ZimVie US Corp LLC in the FDA's device registry (GUDID). Together they are named in 9 adverse event reports in the FDA's MAUDE database, received between Oct 23, 2020 and Sep 25, 2026 — classified as 9 malfunctions.
The most frequently reported specific device problem is “Unintended Movement” (7 reports).
10 FDA recall records name at least one of these models by its device identifier.
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
CERTAIN BELLATEK recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Aug 31, 2020Terminated
Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may cause misalignment, the definitive abutment will not seat in the correct orientation upon attempted placement with the patient
Z-0079-2021 · Root cause: Device Design · Recall details · FDA record ↗
- Aug 31, 2020Terminated
Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may cause misalignment, the definitive abutment will not seat in the correct orientation upon attempted placement with the patient
Z-0078-2021 · Root cause: Device Design · Recall details · FDA record ↗
- Aug 31, 2020Terminated
Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may cause misalignment, the definitive abutment will not seat in the correct orientation upon attempted placement with the patient
Z-0077-2021 · Root cause: Device Design · Recall details · FDA record ↗
- Aug 31, 2020Terminated
Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may cause misalignment, the definitive abutment will not seat in the correct orientation upon attempted placement with the patient
Z-0076-2021 · Root cause: Device Design · Recall details · FDA record ↗
- Aug 31, 2020Terminated
Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may cause misalignment, the definitive abutment will not seat in the correct orientation upon attempted placement with the patient
Z-0075-2021 · Root cause: Device Design · Recall details · FDA record ↗
- Feb 26, 2019Terminated
During manufacturing, the screw stop ledge was not made to specification and location within the abutment, resulting in the screw head seating deeper in the abutment with no positive stop.
Z-2144-2019 · Root cause: Process control · Recall details · FDA record ↗
- Feb 26, 2019Terminated
During manufacturing, the screw stop ledge was not made to specification and location within the abutment, resulting in the screw head seating deeper in the abutment with no positive stop.
Z-2143-2019 · Root cause: Process control · Recall details · FDA record ↗
- Feb 26, 2019Terminated
During manufacturing, the screw stop ledge was not made to specification and location within the abutment, resulting in the screw head seating deeper in the abutment with no positive stop.
Z-2142-2019 · Root cause: Process control · Recall details · FDA record ↗
- Feb 26, 2019Terminated
During manufacturing, the screw stop ledge was not made to specification and location within the abutment, resulting in the screw head seating deeper in the abutment with no positive stop.
Z-2141-2019 · Root cause: Process control · Recall details · FDA record ↗
- Feb 26, 2019Terminated
During manufacturing, the screw stop ledge was not made to specification and location within the abutment, resulting in the screw head seating deeper in the abutment with no positive stop.
Z-2140-2019 · Root cause: Process control · Recall details · FDA record ↗
Most reported CERTAIN BELLATEK problems
Device problems
- Unintended Movement7
- Mechanical Problem2
- Positioning Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
- Insufficient Information1
- No Information1
CERTAIN BELLATEK models
12 models, most reported first. Each model has its own page with its reports, recalls and device details.
- CERTAIN® BELLATEK® IEDAT5ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS1 recall1 report
- CERTAIN® BELLATEK® IEDAN3ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS1 recall0 reports
- CERTAIN® BELLATEK® IEDAN4ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS1 recall0 reports
- CERTAIN® BELLATEK® IEDAN5ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS1 recall0 reports
- CERTAIN® BELLATEK® IEDAT3ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS1 recall0 reports
- CERTAIN® BELLATEK® IEDAT4ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS1 recall0 reports
- CERTAIN® BELLATEK® IEDAT6ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS1 recall0 reports
- CERTAIN® BELLATEK® IIAT3ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS1 recall0 reports
- CERTAIN® BELLATEK® ILDAN3ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS1 recall0 reports
- CERTAIN® BELLATEK® ILDAT3ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS1 recall0 reports
- CERTAIN® BELLATEK® ILDAT4ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS5 reports
- CERTAIN® BELLATEK® ILDAT5ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS3 reports
Recent CERTAIN BELLATEK adverse event reports
The 9 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Unintended Movement
It was reported the screw loosened and bite seems off. Tooth site 30. No harm to patient.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50895009 ↗MalfunctionMay 19, 2026Mechanical Problem
IT WAS REPORTED THAT THE GOLD SCREW WAS NOT ABLE TO SEAT ALL THE WAY. THE SCREW WAS LOOSE AND THUS THE WHOLE CROWN/ABUTMENT HAD MOVEMENT. WE WERE ABLE TO RETRIEVE THE GOLD SCREW, BUT THE ABUTMENT WAS LODGED INTO THE IMPLANT AND WOULD NOT COME OUT. THE ABUTMENT AND CROWN HAD TO BE CUT TO BE REMOVED. TOOTH #13. THE IMPLANT IS OK AND I STILL HAVE THE REMAINING CROWN AND ABUTMENT.. THE ABUT FAILED, AS PER DR ABUTMENT WAS LOOSE, THERE WAS CEMENT IN THE INTERFACE, ABUTMENT WAS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25216357 ↗MalfunctionDec 5, 2022Unintended Movement; Unintended Movement
NO ADDITIONAL EVENT INFORMATION WAS RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15914454 ↗MalfunctionAug 25, 2022Positioning Failure; Mechanical Problem; Positioning Failure; Mechanical Problem
IT WAS REPORTED THAT THERE WAS DAMAGE TO THE UPPER HEX OF IMPLANT DURING SEATING OF ABUTMENT. COULD NOT SEAT ABUTMENT PROPERLY, HAD TO ORDER ANGLED ABUTMENT AND WILL HAVE TO RE-DO CROWN. TOOTH #19.
Patient problems: Insufficient Information
MAUDE report 15292545 ↗MalfunctionFeb 14, 2022Unintended Movement; Unintended Movement
IT IS REPORTED THAT THE ABUTMENT WAS LOOSE IN THE IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13523264 ↗MalfunctionJan 28, 2022Unintended Movement; Unintended Movement
ABUTMENT WHEN ANTICALLY PLACED WAS FINE. SINCE RECEIVING ABUTMENT ¿ THEY¿VE HAD TO REPLACE THE SCREW A FEW TIMES. NOW THE ABUTMENT ROCKS & IS NOT SEATING AT ALL PROPERLY. PATIENT CALLED AND REPORTED IT IS ALREADY LOOSE AGAIN. SCHEDULED TO TIGHTEN IT AND DISCUSS NEXT STEPS. SALES REP REPORTED THE ABUTMENT DOES SEAT, BUT IT WILL NOT STAY SEATED. IT LOOSENS UP EVERY FEW WEEKS DESPITE USING A NEW SCREW OR NOT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13384800 ↗MalfunctionAug 20, 2021Unintended Movement; Unintended Movement
IT WAS REPORTED THAT THE ABUTMENT WILL NOT STAY IN MOUTH, NOT JUST THE SCREW, BUT THE ABUTMENT. THE PATIENT IS BEING REFERRED TO THE SURGEON TO REVIEW THE IMPLANT. TOOTH- 19.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12350810 ↗MalfunctionMar 1, 2021Unintended Movement; Unintended Movement
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11392741 ↗MalfunctionOct 23, 2020Unintended Movement; Unintended Movement
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Information
MAUDE report 10727767 ↗
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
- Eztetic15 models · 382 reports
- Tapered SwissPlus12 models · 376 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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