Tapered Screw-Vent® HC333Recalls & 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
- 11
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00889024014978), received between Jun 26, 2020 and Jun 7, 2024 — classified as 11 malfunctions.
The most frequently reported specific device problem is “Positioning Failure” (8 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 Failure8
- Fracture2
- Mechanical Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions9
- No Information2
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 7, 2024Fracture; Fracture
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19485019 ↗MalfunctionJun 13, 2023Positioning Failure; Mechanical Problem; Positioning Failure; Mechanical Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17116307 ↗MalfunctionNov 23, 2022Positioning Failure; Positioning Failure
IT WAS REPORTED THAT THE HEALING ABUTM DOES NOT SEAT CORRECTLY. THE PROCEDURE WAS CONCLUDED BY PLACING ANOTHER SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15852843 ↗MalfunctionDec 1, 2021Positioning Failure; Positioning Failure
IT WAS REPORTED THAT THE HEALING COLLAR DID NOT FIT INTO THE IMPLANT. ANOTHER HEALING COLLAR WAS USED. TOOTH # 25 (UNIVERSAL).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12911367 ↗MalfunctionDec 1, 2021Positioning Failure; Positioning Failure
IT WAS REPORTED THAT THE HEALING COLLAR DID NOT FIT INTO THE IMPLANT. ANOTHER HEALING COLLAR WAS USED. TOOTH # 25 (UNIVERSAL).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12911306 ↗MalfunctionDec 1, 2021Positioning Failure; Positioning Failure
IT WAS REPORTED THAT THE HEALING COLLAR DID NOT FIT INTO THE IMPLANT. ANOTHER HEALING COLLAR WAS USED. TOOTH # 24 (UNIVERSAL).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12911251 ↗MalfunctionDec 1, 2021Positioning Failure; Positioning Failure
IT WAS REPORTED THAT THE HEALING COLLAR DID NOT FIT INTO THE IMPLANT. ANOTHER HEALING COLLAR WAS USED. TOOTH # 24 (UNIVERSAL).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12911198 ↗MalfunctionSep 20, 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 12494394 ↗MalfunctionJun 24, 2021Mechanical Problem; Mechanical Problem
NO ADDITIONAL OR CORRECTED INFORMATION TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12062893 ↗MalfunctionJan 8, 2021Positioning Failure; Positioning Failure
IT WAS REPORTED THAT THE HEALING ABUTMENT SCREW IS DEFECTIVE, IT CANNOT BE SCREWED. IMPLANT REMAINS PLACED.
Patient problems: No Information
MAUDE report 11138885 ↗MalfunctionJun 26, 2020Fracture; Fracture
IT WAS REPORTED THAT HEALING CAP SCREW WAS BROKEN AND A PORTION OF THE SCREW WAS LEFT IN THE IMPLANT AT SITE NUMBER 4. ATTEMPTED TO REMOVE SCREW PIECE MULTIPLE TIMES WITH NO SUCCESS, DELAY IN RESTORING THE IMPLANT. PATIENT WILL NEED TO RETURN TO REMOVE THE FRAGMENT AN RESTORE IMPLANT. GRAFTING PLACED PRIOR TO PLACEMENT
Patient problems: No Information
MAUDE report 10201654 ↗
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- ATLANTIS® 35502Dentsply Ih, Inc. · Abutment, implant, dental, endosseous54 reports
- Esthetic Abutment 36669Nobel Biocare AB · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS1 recall2 reports
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- Custom Abutments Final AbutmentsInstitut Straumann AG · Abutment, implant, dental, endosseous1 recall0 reports
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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