T2 1850-0830SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540646293), received between Mar 3, 2025 and Mar 3, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. May 22, 2025Open, Classified

   Investigation determined that one lot of the T2 Greater Trochanter Nail (GTN) was labeled as left version but contained a right nail and another lot was labeled as right version but contained a left nail.

   Z-1939-2025 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2025Device Markings/Labelling Problem; Manufacturing, Packaging or Shipping Problem; Device Markings/Labelling Problem; Manufacturing, Packaging or Shipping Problem

  AFTER OPENING THE IMPLANT, THE NAIL WAS PREPARED. WHEN I FELT SOMETHING WAS WRONG AND CHECKED IT BEFORE INSERTING IT INTO THE BODY, I FOUND THAT THE PACKAGE AND THE NAIL ITSELF HAD THE WORD ¿LEFT¿ ENGRAVED ON THEM, BUT IT WAS ACTUALLY A RIGHT-HANDED IMPLANT. THE OPERATION CONTINUED WITH A DIFFERENT SIZE IMPLANT BEING OPENED AND INSERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21510074 ↗