Tapered Screw-Vent® HC355Recalls & reported problems
ZimVie US Corp LLC · Class 2 · Implant
All models of Tapered Screw-Vent (131)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00889024015036), received between Mar 26, 2020 and Sep 10, 2024 — classified as 5 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Positioning Failure4
- Misassembled During Installation1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- No Code Available1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 10, 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 20182278 ↗MalfunctionAug 22, 2023Positioning 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 17597679 ↗MalfunctionMar 24, 2022Positioning Failure; Positioning Failure
IT WAS REPORTED THAT WHEN PLACING TH HEALING ABUTMENT SCREWS, IT WAS IMPOSSIBLE TO SCREW THEM. THE COVER SCREWS AND THE MOUNT SCREWED PERFECTLY INTO THE IMPLANTS, BUT NOT THE HEALING ABUTMENT SCREWS. IMPLANTS REMAIN IN PATIENT'S MOUTH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13891220 ↗MalfunctionOct 22, 2021Positioning Failure; Positioning Failure
IT WAS REPORTED THAT THE HEALING COLLAR CANNOT BE SCREWED INTO THE IMPLANT THREAD. DOCTOR WAS ABLE TO FINISHED THE PROCEDURE USING ANOTHER HEALING COLLAR
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12681118 ↗MalfunctionMar 26, 2020Misassembled During Installation; Misassembled During Installation
IT WAS REPORTED THAT THE DOCTOR WAS NOT ABLE TO SCREW THE HEALING COLLAR TO THE IMPLANT. DOCTOR COMPLETED THE PROCEDURE USING ANOTHER HEALING COLLAR.
Patient problems: No Code Available
MAUDE report 9882007 ↗
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- Esthetic Abutment 36669Nobel Biocare AB · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS1 recall2 reports
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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