VARIAX 629250SRecalls & reported problems
Stryker GmbH · Distal Posterior Lateral Humerus Plate · 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 04546540597731), received between Aug 31, 2021 and Aug 31, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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
- Device Dislodged or Dislocated1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 31, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE CUSTOMER PRESENTED A CASE WHERE A LONG DISTAL POSTERIOR LATERAL OR DISTAL LATERAL HUMERAL VARIAX ELBOW PLATE WAS USED. THEY FACED A COMPLICATION WHICH LED TO STOP USING THE PLATES FOR COMPLEX DISTAL HUMERAL FRACTURES.X-RAYS WERE SHOWN WHERE IT LOOKED LIKE THERE WAS A LOSS OF REDUCTION AFTER SOME TIME.
Patient problems: Insufficient Information
MAUDE report 12391203 ↗
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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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