Tapered Screw-Vent® Implant System ZRA341SRecalls & reported problems
ZimVie US Corp LLC · Class 2 · Implant
All models of Tapered Screw-Vent Implant System (28)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889024021488), received between Feb 15, 2022 and Jan 15, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Fracture” (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
- Fracture3
- Unintended Movement1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 15, 2026Fracture
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #7 HAS A FRACTURED ZRA341S. IMPLANT IS IN PATIENT'S MOUTH WITH OUT ANY ISSUES. ADDITIONAL APPOINTMENT REQUIRED TO PLACE NEW ZRA341S. SYMPTOMS AS A RESULT OF THE EVENT: NONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24087303 ↗MalfunctionOct 30, 2025Fracture; Fracture
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23430009 ↗MalfunctionSep 4, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22961453 ↗MalfunctionFeb 15, 2022Unintended Movement; Unintended Movement
IT WAS REPORTED THAT THE PATIENT CAME IN WITH DISCOMFORT, AND ON EXAMINATION OF TOOTH LOCATION (NOT PROVIDED) NOTICED THAT ONE ABUTMENT WAS LOOSE AND WAS REMOVED. PATIENT RETURNING FOR REPLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13533854 ↗
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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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