T2 ALPHA 2333-1034SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327285901), received between Dec 19, 2022 and Nov 9, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (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.

• InjuryNov 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "USE OF THE PERIPRO SYSTEM ON THIS CASE WAS NOT BECAUSE OF A DEFICIENCY IN PRIOR FIXATION NOR HARDWARE FAILURE WITH THE PREVIOUSLY IMPLANTED T2 ALPHA GT FEMUR AND AXSOS 3 DISTAL FEMUR PLATE. THIS PT WAS BROUGHT TO THE OR WITH AN INFECTION. SO, THE PRESENT DISTAL FEMUR PLATE WAS REMOVED, I & D WAS PERFORMED, AND FEMUR WAS RE-FIXATED WITH THE PERIPRO PLATE COATED IN ANTIBIOTIC CEMENT. "

  Patient problems: Unspecified Infection

  MAUDE report 18107784 ↗
• InjuryDec 19, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE NAIL WAS BROKEN AT THE DISTAL LAG SCREW HOLE. IT WAS AN UNSTABLE CASE DUE TO AN ATYPICAL FEMORAL FRACTURE, AND IT TOOK A LONG TIME FOR THE BONE FUSION. THE REVISION SURGERY WAS PLANNED FOR (B)(6) 2022 WITH LONG GAMMA NAIL OR T2 ALPHA GT NAIL. ANY PLATE MIGHT BE ADDED.

  Patient problems: Failure of Implant; Impaired Healing

  MAUDE report 16010793 ↗