Tapered Screw-Vent® HC335Recalls & 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
- 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 00889024014985), received between Dec 28, 2020 and Aug 20, 2024 — 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. 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 Failure4
- Separation Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- No Information1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryAug 20, 2024Separation Problem; Separation Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20008126 ↗MalfunctionMay 20, 2022Positioning Failure; Positioning Failure
IT WAS REPORTED THAT IT IS IMPOSSIBLE TO SCREW THE HEALING COLLAR INTO THE IMPLANT. PROCEDURE WAS NOT COMPLETED WITH ANOTHER ITEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14461920 ↗InjuryOct 13, 2021Positioning Failure; Positioning Failure
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12625770 ↗MalfunctionAug 19, 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 12340731 ↗MalfunctionDec 28, 2020Positioning Failure; Positioning Failure
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Information
MAUDE report 11076599 ↗
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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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