VARIAX 625204Recalls & reported problems
Stryker GmbH · Volar DR Plate, narrow, R · 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327615791), received between Aug 29, 2025 and Aug 29, 2025 — classified as 1 injury.
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.
Reports received per month
Most reported problems
Device problems
- Break1
- Fracture1
- Material Twisted/Bent1
Patient problems
- Impaired Healing1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 29, 2025Break; Fracture; Material Twisted/Bent; Break; Fracture; Material Twisted/Bent
AS REPORTED: "PLATE NOTED TO DEVELOP SIGNIFICANT BENDING DEFORMITY WITHIN FIRST TWO MONTHS POST OPERATIVE'S, PLATE WENT ON TO FAIL. PROGRESSIVE PAIN AND DYSFUNCTION NOTED PRIOR TO 3-MONTH FOLLOW-UP; DISTAL RADIUS PLATE BROKE AT OBLONG COMPRESSION HOLE. REVISION COMPLETED AND REPLACED WITH SKELETAL DYNAMICS DISTAL RADIUS PLATE.
Patient problems: Impaired Healing; Pain
MAUDE report 22923112 ↗
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- 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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