VariAx 54-25687Recalls & reported problems
Stryker GmbH · VOLAR DR PLATE INTERM. RIGHT LONG · 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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613252614548), received between Feb 18, 2021 and Sep 23, 2025 — 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
- Break1
Patient problems
- Failure of Implant1
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 23, 2025Break; Fracture; Break; Fracture
AS REPORTED: "ON (B)(6) 2025, THE SURGEON OPERATED ON A PATIENT WHOSE INDICATION WAS: ¿VARIOUS OPEN FRACTURES OF THE RIGHT FOREARM.¿ ON (B)(6) 2025, DURING POST-OPERATIVE IMAGING, ONE OF THE PLATES INSERTED WAS FOUND TO BE BROKEN. THE PATIENT THEREFORE HAD TO UNDERGO FURTHER SURGERY ON (B)(6) 2025 TO HAVE THE PLATE REMOVED."
Patient problems: Insufficient Information
MAUDE report 23123103 ↗InjuryFeb 18, 2021Fracture; Fracture
AS REPORTED: "VARIAX DR MEDIUM NARROW LONG PLATE ON (B)(6) 2020 IT BROKE ON THE PROXIMAL SIDE OF THE ELLIPTICAL HOLE. A REPLACEMENT OPERATION OF THE SAME PLATE WAS CARRIED OUT ON (B)(6) 2021. THE FRACTURED PART WAS REFRESHED, THE NUMBER OF SCREWS TO BE FIXED WAS INCREASED FROM THE TIME OF THE FIRST OPERATION, AND IT WAS FIXED AGAIN. DOCTORS SAY THEY DON'T KNOW THE CAUSE."
Patient problems: Failure of Implant
MAUDE report 11346648 ↗
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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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