VARIAX 657412Recalls & reported problems
Stryker GmbH · Bone Screw · Class 2 · Implant
All models of VARIAX (345)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327073751), received between May 13, 2019 and May 13, 2019 — classified as 2 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 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Reaction2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 13, 2019Adverse Event Without Identified Device or Use Problem
COMPLAINANT CALLED ON BEHALF OF PATIENT, STATING PATIENT HAD STRYKER SCREWS AND NAILS USED IN THEIR BROKEN ANKLE IN (B)(6) 2018. SINCE THIS DATE, PATIENT HAS BEEN HAVING ALLERGIC REACTIONS AND IT HAS NOT YET BEEN CONFIRMED WHAT IS THE CAUSE.
Patient problems: Reaction
MAUDE report 8605986 ↗InjuryMay 13, 2019Adverse Event Without Identified Device or Use Problem
COMPLAINANT CALLED ON BEHALF OF PATIENT, STATING PATIENT HAD STRYKER SCREWS AND NAILS USED IN THEIR BROKEN ANKLE IN (B)(6) 2018. SINCE THIS DATE, PATIENT HAS BEEN HAVING ALLERGIC REACTIONS AND IT HAS NOT YET BEEN CONFIRMED WHAT IS THE CAUSE.
Patient problems: Reaction
MAUDE report 8605924 ↗
Other Screw, fixation, bone devices
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- OSTEORAPTOR 72201995Smith & Nephew, Inc. · Screw, fixation, bone253 reports
- Control 360 SK12Treace Medical Concepts, Inc. · Screw, Fixation, Bone195 reports
- HEALIX PEEK ORTHOCORD 222205Medos International Sàrl · Screw, fixation, bone186 reports
- PRECICE® Bone Transport System STP3.5-400Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-225Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-350Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-300Nuvasive Specialized Orthopedics, Inc. · Screw, 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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