Tapered Screw-Vent® Implant System TAC3Recalls & 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
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889024018426), received between Aug 24, 2023 and Dec 30, 2025 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Unintended Movement” (3 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
- Unintended Movement3
- Separation Failure1
- Separation Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 30, 2025Unintended Movement; Unintended Movement
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23920133 ↗MalfunctionDec 30, 2025Unintended Movement; Unintended Movement
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23920109 ↗MalfunctionJan 23, 2024Separation Failure; Unintended Movement; Separation Failure; Unintended Movement
IT WAS REPORTED THAT THE ABUTMENT LOOSENED IN THE PATIENTS MOUTH. THE CUSTOMER TRIED REMOVING THE BUNDLED HEALING CAP FROM THE ABUTMENT BUT IT WOULD NOT LOOSEN, AND THE ABUTMENT ENDED UP LOOSENING FROM THE IMPLANT ALTOGETHER. PROCEDURE WAS COMPLETED WITH A SPARE ABUTMENT THEY HAD IN THE OFFICE TO USE AS A PLACE HOLDER. HAS SINCE REPLACED WITH NEW ABUTMENT AS WELL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18566267 ↗InjuryAug 24, 2023Separation Problem; Separation Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 17610899 ↗
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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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