Virage® 07.01708.021Recalls & 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024328389), received between Sep 5, 2024 and Oct 15, 2024 — classified as 2 malfunctions.
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.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 15, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING SURGERY, A VIRAGE SCREWDRIVER FRACTURED AT THE TIP AND A 5.5MM DIAMETER VIRAGE SCREW BROKE APART AT THE TULIP HEAD. THE PROCEDURE WAS COMPLETED WITH ADDITIONAL SCREW DRIVERS AND SCREWS IN THEIR SET. THERE WAS NO PATIENT IMPACT; HOWEVER, THERE WAS A 10-15 MINUTE DELAY TO GRAB NEW SCREW DRIVERS AND SCREW. THIS IS REPORT TWO OF TWO FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20452819 ↗MalfunctionSep 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE TULIP HEAD OF A 5.5 VIRAGE SCREW POPPED OFF POST-OPERATIVELY. THERE WERE NO REPORTED PATIENT IMPACTS AND THERE ARE NO PLANS FOR A REVISION SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20147052 ↗
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- NA 04.615.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
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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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