Astra Tech Implant System® 25009Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07392532119286), received between Mar 7, 2026 and May 17, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 17, 2026Mechanical Problem

  IT WAS REPORTED THERE WAS A TOOL ISSUE; NO INJURY RESULTED. IMPLANT FELL ON FLOOR FROM DRIVER DURING PLACEMENT: "THE SESSION WAS NOT SUCCESSFULLY COMPLETED WITH ANOTHER IMPLANT. WE HAD TO RESCHEDULE THE APPOINTMENT. ATTACHED IS A PICTURE OF THE IMPLANT-DRIVER THAT WAS USED. WE COULD NOT FIND THE PRODUCT NUMBER ON THE DRIVER."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25196324 ↗
• MalfunctionMar 26, 2026Mechanical Problem

  IT WAS REPORTED THAT THE IMPLANT DRIVER GOT STUCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24697338 ↗
• MalfunctionMar 7, 2026Fracture

  CUSTOMER REPORTED 2 DRIVERS OF IMPLANT, TOOL MALFUNCTION. *THE INSTRUMENT DOESN'T ATTACH WELL TO THE IMPLANT AND WHEN IT DOES IS VERY DIFFICULT TO RELEASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24540627 ↗