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Tapered Screw-Vent® TSV6B16Recalls & 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
4
Deaths reported
0
Injuries reported
4
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889024019409), received between Oct 20, 2022 and Dec 17, 2025 — classified as 4 injuries.

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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 1 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 1 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 1 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem4

Patient problems

  • Osteolysis4
  • Unspecified Infection3

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • InjuryDec 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.

    Patient problems: Osteolysis; Unspecified Infection

    MAUDE report 23827698 ↗
  • InjuryAug 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED IMPLANT AT TOOTH LOCATION # 46 WAS REMOVED DUE TO BONE LOSS AND INFECTION.

    Patient problems: Osteolysis; Unspecified Infection

    MAUDE report 22880291 ↗
  • InjuryMar 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AND BONE LOSS AROUND THE IMPLANT AT TOOTH LOCATION #36. THE IMPLANT WAS REMOVED.

    Patient problems: Osteolysis; Unspecified Infection

    MAUDE report 18904063 ↗
  • InjuryOct 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #16 WAS REMOVED DUE TO MEDICAL BONE LOSS.

    Patient problems: Osteolysis

    MAUDE report 15638269 ↗

Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices

All IMPLANT, ENDOSSEOUS, ROOT-FORM devices →

Sources and updates

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