T2 ALPHA 2335-1238SRecalls & reported problems
Stryker GmbH · Femoral Nail PF, LEFT · Class 2 · Implant
All models of T2 ALPHA (123)
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 07613327284881), received between Sep 15, 2020 and Sep 15, 2020 — classified as 1 injury.
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 Problem1
Patient problems
- Impaired Healing1
- Nonunion/Delayed-union Bone Fracture1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE MANUFACTURER BECAME AWARE OF A POST MARKET CLINICAL FOLLOW-UP REPORT RECEIVED FROM (B)(6), IN USA. THE TITLE OF THIS REPORT IS ¿A RETROSPECTIVE DATA COLLECTION OF THE TREATMENT OF FEMORAL FRACTURES WITH THE FEMORAL NAIL PIRIFORMIS FOSSA (PF) OF THE T2 ALPHA FEMUR ANTEGRADE GT/PF NAILING SYSTEM¿ WHICH IS ASSOCIATED WITH THE STRYKER ¿T2 ALPHA FEMUR ANTEGRADE GT/PF NAILING SYSTEM¿. THIS STUDY INCLUDES RESEARCH DONE ON 18 PATIENTS (19 CASES) REQUIRING SURGERY BETWEEN THE PERIOD MARCH 2019 AND OCTOBER 2019. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE DETAILS FROM THE REPORT, OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED COMPLAINTS. THEREFORE, NEW COMPLAINT WAS INITIATED IN THE SYSTEM FOR THE POST-OPERATIVE COMPLICATION MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES DELAYED UNION. THE REPORT STATES: ¿THE 2ND PATIENT WITH DELAYED UNION OCCURRED 105 DAYS AFTER THE INITIAL SURGERY, IS ONGOING, AND A LOW POWER ELECTROMAGNETIC OSTEOGENIC STIMULATOR DEVICE WAS PRESCRIBED. THE PATIENT IS A (B)(6) YEARS OLD FEMALE, SMOKER, DIABETIC, AND HAS A HISTORY OF HYPOTHYROIDISM, AND RHEUMATOID ARTHRITIS. SHE HAD A STANDING FALL, AND SHE WAS ADMITTED TO THE HOSPITAL WITH A CLOS
Patient problems: Impaired Healing; Nonunion/Delayed-union Bone Fracture
MAUDE report 10538483 ↗
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- PRECICE® Bone Transport System STP3.5-350Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-300Nuvasive 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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