Tapered Screw-Vent® HC345Recalls & 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
Quick summary
This ZimVie Tapered Screw-Vent is a dental implant abutment that connects an implant to a crown or healing piece. The 24 reports mostly describe parts that would not seat or fit properly on the implant, with some loosening, stripped threads or breakage, and mention no deaths and 1 injury. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 24
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00889024015005), received between Feb 17, 2020 and May 21, 2026 — classified as 1 injury, 23 malfunctions.
The most frequently reported specific device problem is “Positioning Failure” (16 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 Failure16
- Fracture2
- Unintended Movement2
- Adverse Event Without Identified Device or Use Problem1
- Mechanical Problem1
- Misassembled1
- Separation Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions20
- No Information3
- No Code Available1
Recent adverse event reports
The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 21, 2026Positioning Failure
THE DOCTOR REPORTED THAT THE ITEM DOES NOT SEAT PROPERLY ON THE IMPLANT AND THAT THE PROCEDURE WAS COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25240214 ↗MalfunctionJul 24, 2025Positioning Failure; Positioning Failure
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22586150 ↗MalfunctionJul 9, 2025Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT A HEALING COLLAR WITH STRIPPED THREADS BECAME STUCK INTO THE IMPLANT. THEY EVENTUALLY WERE ABLE TO REMOVE IT WITHOUT DAMAGE TO THE IMPLANT. TOOTH LOCATION IS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22457516 ↗MalfunctionApr 3, 2025Positioning 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 21762178 ↗MalfunctionJan 22, 2025Fracture; Fracture
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21210660 ↗MalfunctionDec 19, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20977776 ↗MalfunctionAug 7, 2024Unintended Movement; Unintended Movement
IT WAS REPORTED THAT THE PATIENT'S HEALING COLLAR WAS LOOSE AND WAS TIGHTENED WITH A SCREWDRIVER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19928776 ↗MalfunctionNov 15, 2023Positioning Failure; Positioning Failure
DOCTOR REPORTED THAT SCREW DOES NOT FIT IN IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18140669 ↗MalfunctionJul 7, 2023Positioning Failure; Positioning Failure
MALFUNCTION. DOCTOR FOLLOWED THE TSV SURGICAL PROCEDURES TO PLACE THE HEALING COLLAR HC345. HOWEVER, DOCTOR COULD NOT SCREW THE HEALING COLLAR TO THE IMPLANT. SO, HE REPLACED IT WITH A NEW ONE. TOOTH SITE # 14.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17282417 ↗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 17037636 ↗MalfunctionJan 9, 2023Unintended Movement; Unintended Movement
IT WAS REPORTED THAT THE HEALING ABUTMENT SCREW BECAME LOOSENED AT TOOTH SITE #19 AND HAD TO BE REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16121780 ↗MalfunctionJun 1, 2022Positioning Failure; Positioning Failure
IT WAS REPORTED THAT THE HEALING COLLAR DIDN'T ENGAGE TO THE IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14570717 ↗MalfunctionMar 26, 2022Positioning Failure; Positioning Failure
IT WAS REPORTED THAT THE THREADING WAS OFF AND THE ABUTMENT WAS UNABLE TO BE SEATED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13921417 ↗MalfunctionMar 26, 2022Positioning Failure; Positioning Failure
IT WAS REPORTED THAT THE HEALING COLLAR WOULD NOT SEAT DUE TO THE THREADS BEING OFF. PROCEDURE WAS COMPLETED USING ANOTHER HEALING COLLAR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13919334 ↗MalfunctionMar 25, 2022Positioning Failure; Positioning Failure
IT WAS REPORTED THAT THE THREAD OF THE HEALING COLLAR WERE OFF AND THEREFORE IT WOULD NOT SEAT IN THE IMPLANT. PROCEDURE WAS COMPLETED WITH A NEW HEALING COLLAR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13902347 ↗MalfunctionMar 24, 2022Positioning Failure; Positioning Failure
IT WAS REPORTED THAT WHEN THE PRODUCT WAS OPENED FROM YOUR PACKAGING, THREADING WOULD NOT ENGAGE WITH THE IMPLANT/ THREADS. WHEN OPENED ANOTHER, IT THREADED AND SAT PERFECTLY. THE IMPLANT AND ITS THREADING IS FINE AS WE ARE ABLE TO USE ANOTHER AND IT SEATS PERFECTLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13893131 ↗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 13891281 ↗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 13891088 ↗MalfunctionMay 4, 2021Positioning Failure; Positioning Failure
DOCTOR REPORTED THAT DURING OF IMPLANT PLACEMENT, IT WAS NOT POSSIBLE TO TIGHTEN THE SCREW ON THE IMPLANT. ANOTHER SCREW WAS USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11768434 ↗MalfunctionMar 19, 2021Misassembled; Misassembled
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11527188 ↗MalfunctionJan 4, 2021Positioning Failure; Positioning Failure
IT WAS REPORTED THAT THE ABUTMENT COULD NOT BE SCREWED IN.
Patient problems: No Information
MAUDE report 11108769 ↗MalfunctionJan 4, 2021Positioning Failure; Positioning Failure
IT WAS REPORTED THAT THE ABUTMENT COULD NOT BE SCREWED IN.
Patient problems: No Information
MAUDE report 11108715 ↗InjuryDec 17, 2020Separation Failure; Separation Failure
DEC 10 2020 - PER RECEIVED WITH ADDITIONAL EVENT INFORMATION. IMPLANT WAS TORQUED PAST 20 NCM. COULD NOT REMOVE ABUTMENT AND THEN IMPLANT BECAME 2 WEAK AFTER 5 MONTHS OF OSSEOINTEGRATION. IMPLANT WAS THEN REMOVED WITH ABUTMENT AND USING HEMOSTAT, ABUTMENT WAS EVENTUALLY REMOVED.
Patient problems: No Information
MAUDE report 11026751 ↗MalfunctionFeb 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS INDICATED THAT THE HEALING COLLAR FAILED TO BE PLACED.
Patient problems: No Code Available
MAUDE report 9715942 ↗
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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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