CERTAIN GOLD-TITERecalls & reported problems across all models
ZimVie US Corp LLC · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 167
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls
- 0
We found 2 models of CERTAIN GOLD-TITE by ZimVie US Corp LLC in the FDA's device registry (GUDID). Together they are named in 167 adverse event reports in the FDA's MAUDE database, received between Jun 18, 2020 and May 19, 2026 — classified as 7 injuries, 160 malfunctions.
The most frequently reported specific device problem is “Unintended Movement” (83 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 GOLD-TITE problems
Device problems
- Unintended Movement83
- Fracture81
- Adverse Event Without Identified Device or Use Problem2
- Separation Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions130
- No Information17
- Insufficient Information7
- Inflammation4
- Pain4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
- Discomfort1
- Failure of Implant1
CERTAIN GOLD-TITE models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- CERTAIN® GOLD-TITE® IUNIHGABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS151 reports
- CERTAIN® GOLD-TITE® ILRGHGIMPLANT, ENDOSSEOUS, ROOT-FORM16 reports
Recent CERTAIN GOLD-TITE adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMay 19, 2026Unintended Movement
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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25216153 ↗MalfunctionMay 4, 2026Fracture
IT WAS REPORTED A FRACTURE OF THREE OF THE PROSTHETIC SCREWS AT THE THREADED PART IN A PATIENT WITH A MANDIBULAR HYBRID PROSTHESIS ON FOUR IMPLANTS (TOOTH SITE 32,34,42,44), SO IT WAS DECIDED TO REPLACE ALL OF THEM, TAKING INTO ACCOUNT THE POSSIBLE OCLUSAL OVERLOAD. PATIENT SUFFERED PROSTHESIS MOBILITY AND INFLAMMATION.
Patient problems: Inflammation
MAUDE report 25064950 ↗MalfunctionApr 21, 2026Fracture
IT WAS REPORTED THAT THERE WAS A SCREW FRACTURED INSIDE OF THE IMPLANT AT TOOTH SITE #21. THE SCREW WAS SUCTIONED DURING REMOVAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24941729 ↗MalfunctionMar 30, 2026Unintended Movement
IT WAS REPORTED THAT EITHER THE SCREW CAME LOOSE OR DROPPED WHEN SEATING THE ABUTMENT, BUT THE PATIENT MAY HAVE SWALLOWED IT. (IT DISAPPEARED).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24714152 ↗MalfunctionMar 24, 2026Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24682267 ↗MalfunctionMar 5, 2026Fracture
IT WAS REPORTED THAT CLINICIAN CALLED AND REPORTED SCREW FRACTURED AN WAS REMOVED FROM IMPLANT. PATIENT HAS NO IMPACT JUST NEEDS REPLACEMENT SCREW. THE COMPLAINT PRODUCT WAS DISCARDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24524403 ↗MalfunctionFeb 20, 2026Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24399322 ↗MalfunctionJan 9, 2026Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24018704 ↗MalfunctionDec 11, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23778878 ↗MalfunctionDec 5, 2025Unintended Movement; Unintended Movement
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Discomfort; Pain
MAUDE report 23726379 ↗MalfunctionDec 4, 2025Fracture; Fracture
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23715877 ↗MalfunctionOct 15, 2025Fracture; Fracture
IT WAS REPORTED THAT A FRACTURE PORTION WAS FOUND INSIDE THE IMPLANT, SCREW IUNIHG FRACTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23302410 ↗MalfunctionOct 15, 2025Unintended Movement; Unintended Movement
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23301448 ↗MalfunctionOct 15, 2025Unintended Movement; Unintended Movement
IT WAS REPORTED THAT SCREW LOOSENED AND WAS RETIGHTENED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23300620 ↗InjuryOct 15, 2025Fracture; Fracture
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: Inflammation
MAUDE report 23300264 ↗
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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