Tapered Screw-Vent® HC347Recalls & 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00889024015012), received between Jun 10, 2024 and May 20, 2026 — classified as 1 injury, 4 malfunctions.
The most frequently reported specific device problem is “Positioning Failure” (3 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 Failure3
- Fracture1
- Separation Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Pain1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryMay 20, 2026Separation Failure
IT WAS REPORTED THAT THE RESTORATION DOCTOR ATTEMPTED TO REMOVE THE HEALING ABUTMENT AND IT WAS FUSED TO THE IMPLANT AT TOOTH SITE #9. THE GENERAL DENTIST ATTEMPTED TO REMOVE THE HEALING COLLAR AND WAS UNABLE TO DO SO. THE PATIENT WAS REFERRED BACK TO THE SURGEON FOR EVALUATION. THE SURGEON THEN HAD TO APPLY A LARGE AMOUNT OF FORCE TO THE HEALING COLLAR AND WAS UNSUCCESSFUL AT REMOVING IT PRIOR TO THE IMPLANT BREAKING ITS INTEGRATION AND BACKING OUT. A NEW IMPLANT WAS PLACED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Pain
MAUDE report 25233648 ↗MalfunctionJun 13, 2025Fracture; Fracture
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22202278 ↗MalfunctionJun 10, 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 19497654 ↗MalfunctionJun 10, 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 19497635 ↗MalfunctionJun 10, 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 19497627 ↗
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- Esthetic Abutment 36669Nobel Biocare AB · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS1 recall2 reports
- CERTAIN® BELLATEK® IEDAT5ZimVie US Corp LLC · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS1 recall1 report
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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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