N/A HC453Recalls & reported problems
ZimVie US Corp LLC · Class 2 · Implant
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00889024015067), received between May 14, 2021 and Mar 18, 2025 — classified as 2 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Positioning Failure” (4 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
- Positioning Failure4
- Separation Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryMar 18, 2025Positioning Failure; Positioning Failure
IT WAS REPORTED THAT THE PATIENT CAME IN TO HAVE A HEALING ABUTMENT THAT HAD COME OFF PUT BACK ON AND WHEN PLACING THE HEALING ABUTMENT, THE IMPLANT LOST INTEGRATION AND CAME OUT. TOOTH LOCATION #15.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21632979 ↗InjuryMar 20, 2024Separation Problem; Separation Problem
IT WAS REPORTED THAT THE DOCTOR HAD A HARD TIME REMOVING THE HEALING COLLAR AND ONCE IT WAS REMOVED THERE WAS DAMAGE TO THE INTERNAL IMPLANT AND HEALING COLLAR WAS ALSO STRIPPED IN THE PROCESSED. THE IMPLANT WAS INTERNALLY DAMAGED AND THE HEALING COLLAR WERE STRIPPED BECAUSE THE DOCTOR HAD A HARD TIME REMOVING THE HEALING COLLAR DURING CLINICAL PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18939202 ↗MalfunctionSep 20, 2022Positioning Failure; Positioning Failure
IT WAS REPORTED THAT THE HEALING ABUTMENT WOULD NOT INSERT INTO THE IMPLANT 100%. THE DOCTOR TRIED SEVERAL TIMES AND EVEN BACKED OUT THE IMPLANT A BIT. ANOTHER HA WAS USED AND SEATED ON THE FIRST ATTEMPT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15455187 ↗MalfunctionJun 14, 2022Positioning Failure; Positioning Failure
IT WAS REPORTED THAT PATIENT RETURNED TO CLINIC 5 MONTHS AFTER PLACEMENT FOR UNCOVER #29. ABUTMENT WOULD NOT ENGAGE, PLACED DIFFERENT ABUTMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14687661 ↗MalfunctionMay 14, 2021Positioning 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 11824190 ↗
Other ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS devices
- CERTAIN® GOLD-TITE® IUNIHGZimVie US Corp LLC · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS151 reports
- Nobel Biocare® 36662Nobel Biocare AB · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS2 recalls5 reports
- 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
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.