PHALINX 45301001Recalls & reported problems
Wright Medical Technology, Inc. · Class 2 · Implant
All models of PHALINX (10)
Data updated Oct 16, 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 00840420166029), received between May 27, 2026 and May 27, 2026 — 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Implant Pain1
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem
THE MANUFACTURER RECEIVED RWE REPORT NAMED "SAFETY AND PERFORMANCE OF THE PHALINX IMPLANTS UTILIZING THE PREMIER HEALTHCARE DATABASE" THAT CONTAINS COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF PHALINX. THE REPORT DETAILS ANALYSIS PROVIDED FOR PROCEDURES PERFORMED BETWEEN (B)(6) 2016 ¿ (B)(6) 2025. DURING THE REVIEW OF THE REPORT, IT WAS NOT POSSIBLE TO ESTABLISH A SPECIFIC DEVICE DETAIL, PATIENT INFORMATION, AND CURRENTLY NO ADDITIONAL DEVICE INFORMATION IS AVAILABLE; HOWEVER, PATIENT (B)(6) HAD IMPLANT PAIN
Patient problems: Implant Pain
MAUDE report 25299247 ↗InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem
THE MANUFACTURER RECEIVED RWE REPORT NAMED "SAFETY AND PERFORMANCE OF THE PHALINX IMPLANTS UTILIZING THE PREMIER HEALTHCARE DATABASE" THAT CONTAINS COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF PHALINX. THE REPORT DETAILS ANALYSIS PROVIDED FOR PROCEDURES PERFORMED BETWEEN 1 JAN 2016 ¿ 30 MAR 2025. DURING THE REVIEW OF THE REPORT, IT WAS NOT POSSIBLE TO ESTABLISH A SPECIFIC DEVICE DETAIL, PATIENT INFORMATION, AND CURRENTLY NO ADDITIONAL DEVICE INFORMATION IS AVAILABLE; HOWEVER, PATIENT 1 HAD DEVICE REVISION OR REPLACEMENT.
Patient problems: Insufficient Information
MAUDE report 25299058 ↗
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- PRECICE® Bone Transport System STP3.5-350Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-400Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-300Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-200Nuvasive 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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