Tapered Screw-Vent® TW1.25LRecalls & reported problems
ZimVie US Corp LLC · Class 1
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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00889024020207), received between Feb 8, 2021 and Feb 15, 2024 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Fracture” (5 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
- Fracture5
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- No Information1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 15, 2024Fracture; Fracture
IT WAS REPORTED THAT THE DRIVER TIP FRACTURED DURING A PROCEDURE. THE BOTTOM PORTION THAT ENGAGES THE SCREW FRACTURED. THEY WERE ABLE TO COMPLETE THE PROCEDURE WITH ANOTHER DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18711605 ↗MalfunctionApr 20, 2023Fracture; Fracture
IT WAS REPORTED THAT ONE TW1.25L WAS FRACTURED. PROCEDURE HAS BEEN COMPLETED WITH ANOTHER TOOL DRIVER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16776450 ↗MalfunctionAug 30, 2022Fracture; Fracture
IT WAS REPORTED THAT THE DRIVER TIP FRACTURED. NO IMPACT TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15322186 ↗MalfunctionJan 20, 2022Fracture; Fracture
IT WAS REPORTED THAT THE DRIVER TIP FRACTURED DURING A PROCEDURE AT SITE #30. THE FRACTURED TIP WAS SUCCESSFULLY SUCTIONED OUT. THE PROCEDURE WAS COMPLETED USING A BACK UP TOOL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13308154 ↗MalfunctionFeb 8, 2021Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Information
MAUDE report 11292305 ↗
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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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