T2 ALPHA 2331-1038SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327289589), received between Mar 21, 2022 and Jan 22, 2026 — classified as 5 injuries.

The most frequently reported specific device problem is “Fracture” (2 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJan 22, 2026Fracture

  AS REPORTED: "ABOUT TWO MONTHS AFTER THE INITIAL SURGERY, THE PATIENT EXPERIENCED PAIN AND VISITED THE HOSPITAL, WHERE IT WAS FOUND THAT THE NAIL HAD FRACTURED. AT THAT TIME, A FRACTURE OF THE TROCHANTERIC REGION WAS ALSO OBSERVED. REVISION SURGERY IS PLANED AT (B)(6) 2026.".

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 24151804 ↗
• InjuryAug 25, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED: "THE FRACTURE HAS VARUS AND THE DISTAL ADVANCE LOCKING SCREW HAS COME OUT." THE PATIENT EXPERIENCED PAIN. THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2025. THE NAIL WAS REPLACED.

  Patient problems: Pain

  MAUDE report 22885406 ↗
• InjuryAug 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRESENT SWISS TRAUMA FRACTURE REGISTRY (SWTR) IS A PROSPECTIVE, MULTI-CENTER, OBSERVATIONAL STUDY TO COLLECT DATA ON ALL STRYKER TRAUMA AND EXTREMITIES PRODUCTS WITH THE AIM TO ADD TO THE EXISTING CLINICAL EVIDENCE TO SUPPORT THE SAFETY AND PERFORMANCE OF STRYKER IMPLANTS FOR THE APPROVED INDICATIONS FOR USE. THE SWTR CAPTURES DATA EVALUATING THE REAL-WORLD USAGE OF STRYKER IMPLANTS AT TRAUMA CENTERS WITH THE CAPACITY, TRAINING, AND EXPERIENCE TO GATHER CLINICALLY RELEVANT STANDARD OF CARE SAFETY AND PERFORMANCE ENDPOINT DATA. DURING THE REVIEW OF THE REPORT, DELAYED UNION WAS NOTED FOR THIS PATIENT DURING THE FOLLOW UP VISIT.

  Patient problems: Impaired Healing

  MAUDE report 19956381 ↗
• InjuryJul 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A POST-MARKET CLINICAL EVALUATION OF THE TREATMENT OF FEMUR FRACTURES WITH THE FEMORAL NAIL GREATER TROCHANTERIC (GT) OF THE T2 ALPHA FEMUR ANTEGRADE GT/PF NAILING SYSTEM SUBJECT 02-018. NO EVIDENCE OF BONE HEALING S/P 6 MONTHS. TREATMENT: REMOVAL OF HARDWARE; NONUNION NAIL EXCHANGE SX (B)(6) 2021.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 17309560 ↗
• InjuryMar 21, 2022Break; Fracture; Adverse Event Without Identified Device or Use Problem; Break; Fracture; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "A PRIORLY IMPLANTED T2 ALPHA ANTEGRADE NAIL WAS EXPLANTED. A GAMMA NAIL WAS USED AS A REPLACEMENT."

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 13839222 ↗