T2 ALPHA 2337-1142SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327289190), received between Sep 15, 2020 and Feb 10, 2022 — classified as 3 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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "X-RAYS DEMONSTRATE SLOW TO HEAL FRACTURE, NONUNION. " REVISION SURGERY WAS PERFORMED.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 13509383 ↗
• InjuryFeb 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "X-RAYS OF THE RIGHT FEMUR SHOWS STABLE ALIGNMENT AND FIXATION WITH NO SIGNS OF BROKEN SCREWS, HOWEVER, FRACTURE SITE REALLY IS NOT SHOWING MUCH IN TERMS OF CONSOLIDATION FOR SOMEBODY WHO IS SO YOUNG AT 4 MONTHS OUT."

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 11346687 ↗
• 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 DEEP VEIN THROMBOSIS. THE REPORT STATES: ¿PATIENT WAS (B)(6) YEARS OLD MALE, HIS BMI WAS 37.1, HE WAS NONSMOKER AND HAD OSTEOPENIA, HE WAS DIAGNOSED WITH DVT 31 DAYS POST-OPERATIVELY. HIS INJURY WAS DUE TO A FALL FROM HEIGHT AND WAS CLASSIFIED AS 32-B2 CLOSED FRACTURE TYPE. THE DEVICE THAT WAS USED FOR THE SURGERY WAS 11X420 T2 ALPHA FEMORAL NAIL PF, RIGHT, WITH RECON LOCKING MODE. PATIENT WAS PUT

  Patient problems: Thrombosis/Thrombus

  MAUDE report 10538622 ↗