VariAx 54-25687SRecalls & reported problems
Stryker GmbH · VOLAR PLATE INTERMEDIATE RIGHT, LONG · Class 2 · Implant
All models of VARIAX (345)
Data updated Oct 18, 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 07613327005509), received between Dec 10, 2018 and May 17, 2023 — classified as 2 injuries.
The most frequently reported specific device problem is “Break” (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 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Fracture1
Patient problems
- Failure of Implant1
- Implant Pain1
- Reaction1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 17, 2023Break; Fracture; Break; Fracture
IT WAS REPORTED THAT THE VARIAX PLATE BROKE AND THE PATIENT REPORTED PAIN.
Patient problems: Failure of Implant; Implant Pain
MAUDE report 16945486 ↗InjuryDec 10, 2018Adverse Event Without Identified Device or Use Problem
(B)(6) HOSPITAL HAS WRITTEN A FORMAL EMAIL TODAY ASKING FOR THE TITANIUM ALLOY OF VARIAX DR PLATE AND SCREWS. THE INFO IS TO BE USED FOR A PATIENT THAT SEVEN YEARS AGO HAD A VARIAX DR PLATE IMPLANTED AND IS NOW SUFFERING FROM ALLERGIC REACTIONS. THE CUSTOMER / HCP WOULD LIKE TO KNOW THE COMPOSITION OF THE TI ALLOY
Patient problems: Reaction
MAUDE report 8148227 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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