T2 ALPHA 2335-1136SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327285543), received between Sep 15, 2020 and May 17, 2023 — 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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE NAIL WAS REMOVED DUE TO A POSTOPERATIVE INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 16945065 ↗
• 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 UNIVERSITY OF LOUISVILLE, 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 NONUNION AND BROKEN PROXIMAL DISTAL SCREW FOR WHICH REVISION SURGERY WAS PERFORMED. THE REPORT STATES: ¿THE PATIENT WAS A (B)(6) YEARS OLD MALE, BMI 29.0, NEVER A SMOKER WITH A HISTORY OF DIABETES AND SEIZURES. HIS INJURY WAS DUE TO A MOTORCYCLE COLLISION AND WAS CLASSIFIED AS 32-C2 CLOSED FRACTURE. THE PATIENT HAD HYPERTROPHIC NONUNION, DEFINED AS NO SIGNS OF PROPER UNION ASSOCI

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 10538311 ↗