VariAx 54-25376SRecalls & reported problems
Stryker GmbH · VOLAR SMARTLOCK DR PLATE,STAND.LE,SHORT · 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 04546540578693), received between Nov 16, 2018 and Nov 16, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Component Missing” (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
- Component Missing1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 16, 2018Component Missing
IMPLANTING OF THE PLATE USING VARIAXDR WITH LEFT RADIAL DISTAL END FRACTURE OSTEOSYNTHESIS. WHEN CONFIRMING WITH THE IMAGE BEFORE THE SUTURE, SINCE IT WAS TWO PIECES REMAINED LIKE METAL PIECES NEAR THE PROXIMITY FROM THE PLATE INSTALLATION POSITION, IT WAS COLLECTED OUT OF PATIENT BODY. CHECKED THE VARIAXDR'S INSTRUMENTS AND DRILLS USED IN THE OPE, BUT NOT FIND THE INSTRUMENT DAMAGE. IT WAS CONFIRMED THAT THE TIP OF THE HOSPITAL-OWNED KOCHEL FORCEPS IS MISSING, BUT CAN NOT SPECIFY WHETHER THIS IS KOCHEL FORCEPS OR IMPLANT FRAGMENTS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8081327 ↗
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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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