Virage® 07.01702.003Recalls & reported problems
Zimmer Biomet Inc · Class 2
All models of Virage (24)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889024326965), received between Oct 7, 2022 and Oct 7, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
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 16, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 7, 2022Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component
IT WAS REPORTED THAT TWO VIRAGE SCREWS BROKE AT THE WELD AND THREE OTHERS CRACKED AT THE WELD INTRA-OPERATIVELY. ON ONE SCREW, THE SURGEON PUSHED ON IT FROM ABOVE AFTER THE CLOSURE TOP WAS TIGHTENED AND THE LOWER HOUSING BROKE INTO TWO PIECES AT THE WELDS. THEN THE SURGEON NOTICED THE OTHER FOUR SCREWS THAT EITHER BROKE OR CRACKED. ALL OF THE SCREWS WERE REMOVED AND REPLACED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED PATIENT IMPACTS. THIS IS REPORT ONE OF FIVE FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15566231 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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