VARIAX 629589SRecalls & reported problems
Stryker GmbH · Wrist Fusion Plate Short Bend · 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 07613327131499), received between Feb 26, 2026 and Feb 26, 2026 — 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture1
Patient problems
- Muscle Weakness/Atrophy1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 26, 2026Fracture
AS REPORTED: "ON (b)(6) 2024, THE PATIENT UNDERWENT SURGERY ON HIS LEFT WRIST. IT WAS FUSED USING THE VARIAX 2 WRIST FUSION. IN (b)(6) 2025, IT WAS DISCOVERED THAT THE PLATE HAD BROKEN. THE MATERIAL WAS THEN REMOVED ON (b)(6) 2025. THE PATIENT REPORTED PAIN IN THE WRIST AND A LACK OF STRENGTH IN HIS DOMINANT HAND."
Patient problems: Muscle Weakness/Atrophy; Pain
MAUDE report 24457741 ↗
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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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