T2 ALPHA 2337-1244SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327288643), received between Sep 15, 2020 and Sep 16, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Separation Problem” (1 report).

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.

• InjurySep 16, 2020Separation Problem; Separation 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 PROXIMAL INTERLOCKING SCREW MIGRATION WHICH OCCURRED AT 55 DAYS AFTER SURGERY FOLLOWED BY SCREW REMOVAL. THE REPORT STATES: ¿MIGRATING PROXIMAL INTERLOCKING SCREW: THIS OCCURRED 55 DAYS AFTER SURGERY. PATIENT WAS (B)(6) YEARS OLD MALE, BMI 21.3, SMOKER, WITH HISTORY OF SEIZURES, DRUG ABUSE, AND WEAKNESS IN ARMS AND LEGS. HIS INJURY WAS DUE TO A MOTORCYCLE COLLISION AND WAS CLASSIFIED AS 31-A2, TYP

  Patient problems: Failure of Implant

  MAUDE report 10542236 ↗
• 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 NONUNION. THE REPORT STATES: ¿PATIENT WAS (B)(6) YEARS OLD MALE, BMI 21.3, SMOKER, WITH HISTORY OF SEIZURES, DRUG ABUSE, AND WEAKNESS IN ARMS AND LEGS. HIS INJURY WAS DUE TO A MOTORCYCLE COLLISION AND WAS CLASSIFIED AS 31-A2, TYPE II GUSTILO FRACTURE. THE DEVICE USED FOR THE INITIAL FIXATION SURGERY WAS 12X440 T2 ALPHA FEMORAL NAIL PF, RIGHT, WITH RECON LOCKING MODE. THE PROXIMAL SCREW MIGRATED AN

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 10538240 ↗