CERTAIN® GOLD-TITE® IUNIHGRecalls & reported problems
ZimVie US Corp LLC · CERTAIN® GOLD-TITE® HEXED SCREW · Class 2 · Implant
Quick summary
This ZimVie Certain Gold-Tite hexed screw is used to secure dental abutments on implants. Its 152 adverse event reports include 7 injuries and no deaths, and many describe screws that loosen, fracture or fail to seat fully, causing crowns and abutments to shift or requiring removal. In the past 12 months there were 12 reports, down from 37 in the year before. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 151
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 151 adverse event reports that list this exact device (DI 00844868008538), received between Jun 18, 2020 and May 19, 2026 — classified as 7 injuries, 144 malfunctions.
The most frequently reported specific device problem is “Unintended Movement” (81 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Unintended Movement81
- Fracture67
- Adverse Event Without Identified Device or Use Problem2
- Separation Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions121
- No Information13
- Insufficient Information5
- Inflammation4
- Pain4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Discomfort1
- Failure of Implant1
Recent adverse event reports
The 25 most recent of 151 reports, 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 ↗MalfunctionSep 12, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23043146 ↗MalfunctionAug 27, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22903212 ↗MalfunctionAug 27, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22903108 ↗MalfunctionAug 25, 2025Fracture; Fracture
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22891287 ↗MalfunctionAug 12, 2025Fracture; Fracture
IT WAS REPORTED THAT THE SCREW FRACTURED INSIDE OF THE IMPLANT. THE IMPLANT REMAINS IN THE PATIENT'S MOUTH WITHOUT ANY ISSUES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22784137 ↗MalfunctionJul 1, 2025Unintended Movement; Unintended Movement
IT WAS REPORTED THAT THE SCREW LOOSENED AT TOOTH SITE #19 A FEW MONTHS AFTER THE ABUTMENT WAS SEATED IN THE PATIENT'S MOUTH AND THE SCREW WAS ULTIMATELY REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22374759 ↗MalfunctionJul 1, 2025Unintended Movement; Unintended Movement
IT WAS REPORTED A LOOSENING DETECTED DUE TO CROWN MOBILITY ON TOOTH SITE #25. THE CROWN WAS FRACTURED. PROCEDURE WAS COMPLETED CHANGING THE SCREW. NO IMPACT ON THE PATIENT REPORTED. PATIENT WILL RETURN TO PLACE THE NEW PROSTHESIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22368827 ↗MalfunctionJun 25, 2025Unintended Movement; Unintended Movement
IT WAS REPORTED THAT THE SCREW LOOSENED IN THE PATIENT'S MOUTH. REMOVED AND REPLACED WITH ANOTHER SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22333525 ↗MalfunctionMay 28, 2025Fracture; Fracture
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22096642 ↗MalfunctionMay 21, 2025Unintended Movement; Unintended Movement
IT WAS REPORTED THAT ABUTMENT CAME LOOSE WOULDN¿T SEAT ALL THE WAY AND PATIENT IN PATIENTS MOUTH, SWALLOWED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22065661 ↗
Other ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS devices
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- CERTAIN® IUNIHTZimVie US Corp LLC · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS67 reports
- ATLANTIS® 35502Dentsply Ih, Inc. · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS66 reports
- ATLANTIS® 35502Dentsply Ih, Inc. · Abutment, implant, dental, endosseous54 reports
- Esthetic Abutment 36669Nobel Biocare AB · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS1 recall2 reports
- CERTAIN® BELLATEK® IEDAT5ZimVie US Corp LLC · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS1 recall1 report
- Custom Abutments Final AbutmentsInstitut Straumann AG · Abutment, implant, dental, endosseous1 recall0 reports
- Legacy™ SMARTbase, Narrow, NE 8745-80NNEImplant Direct Sybron Manufacturing LLC · Abutment, Implant, Dental, Endosseous1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.