T2 ALPHA 2341-0010SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327365030), received between Jan 2, 2024 and Mar 6, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Remove” (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 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.

• InjuryMar 6, 2025Difficult to Remove; Difficult to Remove

  AS REPORTED: "DURING THE T2 ALPHA TIBIA REMOVAL SURGERY, THE END CAP COULD NOT BE REMOVED, AND THE SURGERY WAS FINISHED WITH THE T2 NAIL REMAINING TO THE PATIENT. ALSO TWO SCREWDRIVER TIPS WERE DAMAGED BY THE TORQUE."

  Patient problems: Foreign Body In Patient

  MAUDE report 21536709 ↗
• MalfunctionJan 2, 2024Difficult to Remove; Difficult to Remove

  AS REPORTED: "THE HEAD OF THE END CAP SLIPPED DURING REMOVAL, CAUSING REMOVAL DIFFICULTY. THE END CAP WAS LOCKED TIGHTLY AND THE TIP OF THE SCREWDRIVER WAS DEFORMED. THE REVERSE THREADED SCREWDRIVER OF THE REMOVAL INSTRUMENT WAS ALSO BROKEN. OTHER INSTRUMENTS USED WERE ALSO DAMAGED. FINALLY THE END CAP AND OTHER IMPLANTS WERE REMOVED FROM THE PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18425683 ↗