Tapered Screw-Vent® Implant System TACW2Recalls & 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889024018464), received between Nov 28, 2024 and Sep 25, 2025 — classified as 4 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
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2025Fracture; Fracture
IT WAS REPORTED THAT PATIENT CAME IN DUE TO CONCERNS WITH MOBILITY OF UPPER SCREW RETAINED DENTURE. TACW2 FRACTURED. REMOVED AND REPLACED WITH NEW MUA'S SCREWED DENTURE BACK INTO IMPLANTS NO MOBILITY NOTED. PATIENT WEARS BITE SPLINT TO PROTECT IMPLANTS/DENTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23144138 ↗MalfunctionNov 28, 2024Unintended 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 20804109 ↗MalfunctionNov 28, 2024Unintended 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 20804096 ↗MalfunctionNov 28, 2024Unintended 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 20804001 ↗
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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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