VARIAX 629284Recalls & reported problems
Stryker GmbH · Distal Medial Humerus Plate - Extended · 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 07613154970629), received between Jul 22, 2024 and Jul 22, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Positioning Failure” (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.
Reports received per month
Most reported problems
Device problems
- Positioning Failure1
Patient problems
- Perforation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 22, 2024Positioning Failure; Positioning Failure
THE CUSTOMER REPORTED THE FOLLOWING: "I HAVE BEEN INFORMED OF AN INCIDENT THAT OCCURRED DURING THE INSTALLATION OF A VARIAX PLATE REF. 629284: A FRAGMENT OF PLATE DETACHED ITSELF IN THE FORM OF A THREAD DURING SCREWING, CAUSING A WOUND ON THE SURGEON'S RIGHT HAND. AN ACCIDENT DUE TO EXPOSURE TO BLOOD AND A WORK-RELATED ACCIDENT WERE REPORTED."
Patient problems: Perforation
MAUDE report 19792458 ↗
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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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