VariAx 54-25396SRecalls & reported problems
Stryker GmbH · VOLAR SMARTLOCK DR PLATE,STANDARD,SHORT · Class 2 · Implant
All models of VARIAX (345)
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 04546540578808), received between Feb 14, 2022 and Feb 14, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (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
- Device Difficult to Setup or Prepare1
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.
MalfunctionFeb 14, 2022Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
AS REPORTED: "WHEN THE LOCKING SCREW WAS SCREWED IN, IT SPUN AND HAD NO HOLD IN THE PLATE. WHEN THE DOCTOR ATTEMPTED TO UNSCREW THE SCREW, IT ALSO SPUN AND COULD THEREFORE NOT BE REMOVED. IT REMAINED IN THE PLATE AND THE TREATMENT WAS LEFT AS IT WAS."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13523774 ↗
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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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