Tapered Screw-Vent® HC443Recalls & reported problems
ZimVie US Corp LLC · Class 2 · Implant
All models of Tapered Screw-Vent (131)
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 00889024015043), received between Feb 22, 2021 and Aug 22, 2023 — classified as 4 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Positioning Failure4
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 22, 2023Positioning Failure; Positioning Failure
DOCTOR REPORTED THAT GINGIVA FORMER COULD NOT SCREW PROPERLY, THREADS COULD BE DAMAGED. PROCEDURE WAS COMPLETED WITH A NEW DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17597722 ↗MalfunctionMay 20, 2022Positioning Failure; Material Twisted/Bent; Positioning Failure; Material Twisted/Bent
IT IS REPORTED THAT THE SCREW WOULD NOT ENGAGE, SEEMS BENT OR AT AN ANGLE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14462583 ↗MalfunctionNov 22, 2021Positioning Failure; Positioning Failure
NO ADDITIONAL OR CORRECTED INFORMATION TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12857354 ↗MalfunctionFeb 22, 2021Positioning Failure; Positioning Failure
IT WAS REPORTED THAT DURING THE FINAL ROTATION THE FINAL ABUTMENT COULD NOT BE SEATED. TOOTH #19.
Patient problems: Insufficient Information
MAUDE report 11358954 ↗
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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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