Tapered Screw-Vent® HC343Recalls & reported problems
ZimVie US Corp LLC · Class 2 · Implant
- Adverse event reports
- 17
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00889024014992), received between Dec 27, 2019 and Jan 26, 2026 — classified as 17 malfunctions.
The most frequently reported specific device problem is “Positioning Failure” (9 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Positioning Failure9
- Component Misassembled3
- Adverse Event Without Identified Device or Use Problem1
- Fracture1
- Mechanical Problem1
- Separation Problem1
- Unintended Movement1
Patient problems
- No Clinical Signs, Symptoms or Conditions10
- No Information7
Recent adverse event reports
The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 26, 2026Mechanical Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #12 HAD A DISLODGED HC343. THE HEALING COLLAR WAS REPLACED WITHOUT DIFFICULTY THE SAME DAY. THE HEALING COLLAR WAS DISCARDED AND WILL NOT BE SENT BACK TO AID IN THE INVESTIGATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24184243 ↗MalfunctionJul 18, 2024Positioning Failure; Positioning Failure
PROBLEM OF SCREWING INTO THE IMPLANT DURING PLACEMENT. PROCEDURE COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19769722 ↗MalfunctionJul 18, 2024Positioning 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 19769651 ↗MalfunctionJan 11, 2024Positioning 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 18491641 ↗MalfunctionSep 15, 2023Positioning Failure; Positioning Failure
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17756789 ↗MalfunctionJun 1, 2023Positioning Failure; Positioning Failure
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17037675 ↗MalfunctionApr 14, 2023Positioning Failure; Positioning Failure
NO ADDITIONAL OR CORRECTED INFORMATION TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16748130 ↗MalfunctionFeb 17, 2023Fracture; Fracture
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THIS TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16396977 ↗MalfunctionJan 25, 2023Separation Problem; Separation Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16240034 ↗MalfunctionOct 15, 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 12639629 ↗MalfunctionNov 12, 2020Unintended Movement; Unintended Movement
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Information
MAUDE report 10829014 ↗MalfunctionOct 2, 2020Positioning Failure; Positioning Failure
IT WAS REPORTED THAT THE HEALING COLLAR DO NOT SCREW INTO THE IMPLANT. PROCEDURE COMPLETED WITH ANOTHER HEALING COLLAR.
Patient problems: No Information
MAUDE report 10618863 ↗MalfunctionSep 16, 2020Positioning Failure; Positioning Failure
IT WAS REPORTED THAT THE HEALING ABUTMENT DID NOT SCREW PROPERLY TO THE IMPLANT. ANOTHER HEALING ABUTMENT WAS PLACED.
Patient problems: No Information
MAUDE report 10540328 ↗MalfunctionApr 29, 2020Component Misassembled; Component Misassembled
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Information
MAUDE report 10008948 ↗MalfunctionApr 29, 2020Component Misassembled; Component Misassembled
IT WAS REPORTED THAT THE HEALING COLLAR HC343 - (GINGIVA FORMER) COULD NOT BE SCREWED AND IT COULD NOT BE PLACED, THE TIP OF THE SCREW DOES NOT SEAT.
Patient problems: No Information
MAUDE report 10008943 ↗MalfunctionApr 7, 2020Component Misassembled; Component Misassembled
IT WAS REPORTED THAT THE HEALING COLLAR HC343 - (GINGIVA FORMER) COULD NOT BE SCREWED AND IT COULD NOT BE PLACED, THE TIP OF THE SCREW DOES NOT SEAT.
Patient problems: No Information
MAUDE report 9932444 ↗MalfunctionDec 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Information
MAUDE report 9523044 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.