VariAx 40-15091Recalls & reported problems
Stryker GmbH · L-PLATE, LEFT · Class 2 · Implant
All models of VARIAX (345)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613154627998), received between Jan 3, 2020 and Jan 3, 2020 — classified as 3 injuries.
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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem3
Patient problems
- Injury3
- Reaction3
- Inflammation1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJan 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
OPEN REDUCTION AND INTERNAL FIXATION OF THE LEFT MIDFOOT. METALOSIS WAS OBSERVED DURING REMOVAL.
Patient problems: Injury; Reaction
MAUDE report 9549334 ↗InjuryJan 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RIGHT MIDFOOT OPEN REDUCTION + INTERNAL FIXATION + LISFRANC STABILISATION. METALOSIS WAS OBSERVED DURING REMOVAL.
Patient problems: Inflammation; Injury; Reaction
MAUDE report 9549297 ↗InjuryJan 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
VARIAX FOOT PLATE METALOSIS NOTICED UPON REMOVAL ON (B)(6) 2019 BY SURGEON. IMPLANTED ON (B)(6) 2019. REMOVAL NOT FOR NON-UNION, JUST REMOVAL OF METALWARE.
Patient problems: Injury; Reaction
MAUDE report 9549149 ↗
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- PRECICE® Plating System LP4.5-PLF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls3 reports
- PRECICE® Plating System LP4.5-MRT4BNuvasive 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-PLF40Nuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls0 reports
- PRECICE® Plating System LP4.5-PRT42Nuvasive 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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