VariAx 40-35616Recalls & reported problems
Stryker GmbH · LOCKING SCREW, T10 · Class 2 · Implant
All models of VARIAX (345)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613154628698), received between Aug 23, 2018 and Sep 16, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Defective 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
- Adverse Event Without Identified Device or Use Problem1
- Defective Component1
Patient problems
- Eczema1
- Foreign Body Reaction1
- No Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT UNDERWENT ANKLE SURGERY ON (B)(6) 2024, USING A 9-HOLE 1/3 TUBULAR PLATE WITH A COMBINATION OF LOCKING AND NON-LOCKING SCREWS, AS WELL AS TWO 4.0 MM PARTIALLY THREADED CANNULATED SCREWS WITH WASHERS. THE PATIENT DEVELOPED ECZEMA SHORTLY AFTER SURGERY, POSSIBLY DUE TO AN ALLERGIC REACTION TO THE IMPLANT. A PATCH TEST WITH A LOCAL ALLERGIST IS PENDING TO DETERMINE IF THE PLATE AND SCREWS ARE THE CAUSE. THE METALLIC COMPOSITION OF THE IMPLANTS IS UNCLEAR, AND MORE INFORMATION IS NEEDED TO DETERMINE IF THEY ARE MADE OF TITANIUM OR ALLOYS. THE PATIENT'S REPRESENTATIVE EMPHASIZED THAT THEY ARE NOT FILING A COMPLAINT OR REQUESTING AN INVESTIGATION BUT ARE SEEKING DETAILS ON THE METALS USED IN THE IMPLANT TO RULE OUT A METAL ALLERGY.
Patient problems: Eczema; Foreign Body Reaction
MAUDE report 20222498 ↗MalfunctionAug 23, 2018Defective Component
IT WAS NOT LOCKED THE SCREW FOR VARIAX DURING PROCEDURE. REPLACED ANOTHER SCREW AND COMPLETE THE PROCEDURE.
Patient problems: No Information
MAUDE report 7810900 ↗
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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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