Virage® 07.01708.012Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024328297), received between Jun 25, 2024 and Sep 23, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Fracture” (2 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture2
Patient problems
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 23, 2024Fracture; Fracture
IT WAS REPORTED THE SHAFT OF A VIRAGE POLYAXIAL SCREW FRACTURED AT THE NECK UPON FINAL ROTATIONS OF PLACING THE SCREW. THE PROCEDURE WAS COMPLETED USING ANOTHER VIRAGE POLYAXIAL SCREW AND THERE WAS NO PATIENT IMPACT, HOWEVER, THE MAJORITY PORTION OF THE SHANK WAS LEFT IN THE PATIENT AS IT WAS IN SOLID BONE AND WOULD NOT HAVE BEEN ABLE TO BE RETRIEVED.
Patient problems: Foreign Body In Patient
MAUDE report 20278727 ↗InjuryJun 25, 2024Fracture; Fracture
IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO REPLACE A VIRAGE OCT CONSTRUCT AFTER TWO SCREWS FRACTURED. THE PATIENT EXPERIENCED A FALL FROM THEIR BED SIX DAYS AFTER THE INITIAL SURGERY. THIS IS REPORT TWO OF TWO FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19608533 ↗
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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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