VariAx 54-25401Recalls & reported problems
Stryker GmbH · LATERAL DR PLATE, LONG · Class 2 · Implant
All models of VARIAX (345)
Data updated Oct 18, 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 07613153068440), received between Sep 18, 2015 and Sep 18, 2015 — classified as 1 malfunction.
The most frequently reported specific device problem is “Hole In Material” (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
- Hole In Material1
Patient problems
- Bone Fracture(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2015Hole In Material
TRAUMA SURGEON USED OUR VARIAX DISTAL RADIUS KIT AS THE TRIMED & SYNTHES SETS HAD HOLES IN THEM. WRIST FRACTURE VERY COMMINUTED. USED VARIAX RADIAL COLUMN PLATE LONG AND WHEN PLACING CORTICAL 2.7 SCREW INTO THE RECTANGLE HOLE IT WENT STRAIGHT THROUGH PLATE. TOOK OFF PLATE AND USED VARIAX DORSAL PLATE. COMPLETED PROCEDURE.
Patient problems: Bone Fracture(s)
MAUDE report 5088726 ↗
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- PRECICE® Plating System LP4.5-MRT4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls3 reports
- PRECICE® Plating System LP4.5-PLF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls3 reports
- PRECICE® Plating System LP4.5-DRF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls1 report
- PRECICE® Plating System LP4.5-MLT42Nuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls0 reports
- PRECICE® Plating System LP4.5-MRT42Nuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls0 reports
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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