VariAx 40-15042Recalls & reported problems
Stryker GmbH · BROAD STRAIGHT PLATE, MEDIUM · 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613154627899), received between Apr 8, 2020 and Apr 8, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Fracture” (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
- Fracture1
- Material Erosion1
- Migration1
Patient problems
- Failure of Implant1
- Injury1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 8, 2020Material Erosion; Fracture; Migration; Material Erosion; Fracture; Migration
IT WAS REPORTED THAT THE PATIENT'S RIGHT FOOT WAS REVISED DUE TO PAIN. A PRE-REVISION X-RAY SHOWED THE PLATE HAD BROKEN. INTRA-OPERATIVELY, IT WAS NOTICED THAT THE PLATE WAS BLACKENED, SOME OF THE METAL HAD ERODED AWAY, AND THE PLATE SUBSIDED INTO THE PATIENT'S BONE. THE PLATE AND 5 SCREWS WERE REVISED.
Patient problems: Failure of Implant; Injury; Pain
MAUDE report 9936347 ↗
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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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