Tapered Screw-Vent Implant System HC445Recalls & reported problems
ZimVie US Corp LLC · Class 2 · Implant
All models of Tapered Screw-Vent Implant System (28)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00889024015050), received between Jan 30, 2020 and May 27, 2024 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Positioning Failure” (5 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Positioning Failure5
- Misassembled1
- Separation Failure1
- Unintended Movement1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- No Information2
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 27, 2024Unintended Movement; Unintended Movement
IT WAS REPORTED THE HEALING ABUTMENT LOOSE, IMPOSSIBLE TO SCREW IT BACK INTO THE IMPLANT. ANOTHER HEALING ABUTMENT HAD TO BE PLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19400029 ↗MalfunctionApr 29, 2024Separation Failure; Separation Failure
NO ADDITIONAL OR CORRECTED INFORMATION TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19203208 ↗MalfunctionJan 24, 2024Positioning Failure; Positioning Failure
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18574279 ↗MalfunctionDec 13, 2022Positioning 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 15971679 ↗MalfunctionApr 25, 2022Positioning Failure; Positioning Failure
CUSTOMER REPORTED AFTER UNCOVERING THE IMPLANT TRIED TO PLACE HEALING COLLAR 4.5MMX5MM. HEALING COLLAR WOULD NOT THREAD TO THE IMPLANT. PROCEDURE WAS COMPLETED USING ANOTHER HEALING COLLAR. TOOTH LOCATION NOT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14192928 ↗MalfunctionJul 2, 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 12112057 ↗MalfunctionMar 26, 2020Positioning Failure; Positioning Failure
IT WAS REPORTED THAT THE HEALING ABUTMENT WOULD NOT SEAT ON THE IMPLANT. THEY WERE ABLE TO COMPLETE THE PROCEDURE WITH ANOTHER SAME SIZE HEALING ABUTMENT. TOOTH LOCATION UNKNOWN.
Patient problems: No Information
MAUDE report 9886127 ↗MalfunctionJan 30, 2020Misassembled; Misassembled
DOCTOR INDICATED THAT IT WAS IMPOSSIBLE TO SCREW THE HEALING COLLAR. PROCEDURE WAS COMPLETED WITH ANOTHER ABUTMENT.
Patient problems: No Information
MAUDE report 9646695 ↗
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- 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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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