T2 ALPHA 2341-0930SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327290875), received between Apr 25, 2024 and Mar 20, 2026 — classified as 1 injury, 1 malfunction.

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

• MalfunctionMar 20, 2026Positioning Failure

  AS REPORTED: "AN ADVANCED SCREW 35MM WAS INSERTED INTO THE MOST PROXIMAL OBLIQUE HOLE, AND THE COUNTER BORING DRILL MANUAL WAS PERFORMED AS PER THE PROCEDURE MANUAL. HOWEVER, SINCE THE SCREW DID NOT ADVANCE SMOOTHLY, IT WAS REPLACED WITH A DIFFERENT SIZE SCREW, WHICH ALLOWED SUCCESSFUL INSERTION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24653742 ↗
• InjuryApr 25, 2024Mechanical Jam; Mechanical Jam

  AS REPORTED: "ADVANCED LOCKING SCREW BOUND UP IN ALPHA TIBIA NAIL. WOULD NOT ADVANCE OR BACK UP. CUT SCREW TIP WITH BOLT CUTTER. SCREW PROMINENT. MAY NEED ADDITIONAL SURGERY TO REMOVE. REVISION SURGERY IS PLANNED, BUT NOT YET SCHEDULED. BONE QUALITY SEEMED NORMAL. THE LOCKING SCREW WAS PLACED IN THE PROXIMAL, OBLIQUE HOLE OF THE JIG AND INTO THE NAIL."

  Patient problems: Failure of Implant

  MAUDE report 19188047 ↗