GOLD-TITERecalls & reported problems across all models
ZimVie US Corp LLC · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 32
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls
- 0
We found 3 models of GOLD-TITE by ZimVie US Corp LLC in the FDA's device registry (GUDID). Together they are named in 32 adverse event reports in the FDA's MAUDE database, received between Sep 28, 2020 and Feb 11, 2026 — classified as 2 injuries, 30 malfunctions.
The most frequently reported specific device problem is “Fracture” (21 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 GOLD-TITE problems
Device problems
- Fracture21
- Unintended Movement12
Patient problems
- No Clinical Signs, Symptoms or Conditions31
- No Information1
GOLD-TITE models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- GOLD-TITE® UNISGABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS20 reports
- GOLD-TITE® UNIHGABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS7 reports
- GOLD-TITE® GSH30ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS5 reports
Recent GOLD-TITE adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionFeb 11, 2026Unintended Movement
IT WAS REPORTED THAT THE SCREWS KEEP COMING LOOSE IN THE PATIENTS¿ MOUTH. THE SCREWS WERE RETIGHTENED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24316223 ↗MalfunctionFeb 11, 2026Unintended Movement
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24316114 ↗InjuryDec 11, 2025Fracture; Fracture
IT WAS REPORTED THAT THE PATIENT LOST THE IMPLANT AT TOOTH SITE 34 DUE TO NON-INTEGRATION. ON 2021 GOLDTITE SCREW AT TOOTH SITE 35 FRACTURED AND THE SCREW WAS REMOVED. ON (B)(6) 2025 GOLDTITE SCREW AT TOOTH SITE 36 FRACTURED, BUT THIS TIME IT WAS IMPOSSIBLE TO REMOVE THE SCREW. DOCTOR DECIDED TO PUT TO SLEEP IMPLANT AT TOOTH SITE 36, AND A NEW IMPLANT WILL BE PLACED AT TOOTH SITE 34. IMPLANT AT TOOTH SITE 36 WAS PLACED ON (B)(6) 2009. THIS REPORT REFERS TO SCREW FRACTURE AT TOOTH SITE 36.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23776296 ↗MalfunctionNov 17, 2025Fracture; Fracture
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23570640 ↗MalfunctionMar 27, 2025Fracture; Unintended Movement; Fracture; Unintended Movement
IT WAS REPORTED THAT THE PATIENT PRESENTED WITH LOOSE SCREW, THE SCREW FRACTURED WHEN THE CLINICIAN WAS RE-TORQUEING IN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21712109 ↗MalfunctionMar 17, 2025Unintended Movement; Unintended Movement
IT WAS REPORTED THAT SCREW LOOSENING AND WAS RETIGHTENED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21617916 ↗MalfunctionJan 29, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21267452 ↗MalfunctionJan 29, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21267418 ↗MalfunctionJan 29, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21267321 ↗MalfunctionJan 29, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21267286 ↗MalfunctionNov 18, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20703859 ↗MalfunctionNov 18, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20703821 ↗MalfunctionJan 11, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18496419 ↗MalfunctionJan 11, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18496411 ↗MalfunctionSep 26, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17817003 ↗
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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