Astra Tech Implant System® 25011Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07392532119309), received between Mar 24, 2026 and Jun 22, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 22, 2026Fracture

  IT WAS REPORTED THAT THERE WAS A TOOL MALFUNCTION WHERE THERE WAS DAMAGE TO THE TOOL HEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25579846 ↗
• MalfunctionMay 26, 2026Mechanical Problem

  IT WAS REPORTED THAT A TOOL MALFUNCTION OCCURRED. BOTH IMPLANT DRIVERS REMAINED STUCK IN THE DRILL EXTENSION AND COULD NO LONGER BE REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25284455 ↗
• MalfunctionApr 8, 2026Mechanical Problem

  CUSTOMER REPORTED THE TOOL ISSUE: THE IMPLANT DRIVER CANNOT GET STUCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24815961 ↗
• MalfunctionMar 24, 2026Mechanical Problem

  CUSTOMER REPORTED THERE WAS A TOOL ISSUE. THE IMPLANT DRIVER PEEK WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24672906 ↗