Astra Tech Implant System® 25010Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07392532119293), received between Feb 11, 2026 and Jul 14, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (6 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 14, 2026Fracture

  IT WAS REPORTED THERE WAS A TOOL ISSUE; THE IMPLANT DRIVER IS BROKEN AND CANNOT GET STUCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25815240 ↗
• MalfunctionJul 7, 2026Mechanical Problem

  IT WAS REPORTED THAT THERE WAS A TOOL MALFUNCTION WHERE THE TOOL DOES NOT PICK UP IMPLANTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25731311 ↗
• MalfunctionJun 26, 2026Mechanical Problem

  IT WAS REPORTED THAT THERE WAS A TOOL MALFUNCTION WHERE THE HANDLE OF THE SURGICAL SCREWDRIVER GOT STUCK WITH THE DRIVER AND COULD NOT BE REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25637174 ↗
• MalfunctionJun 23, 2026Separation Failure

  IT WAS REPORTED THAT THERE WAS A TOOL MALFUNCTION WHERE THE IMPLANT DRIVER CANNOT BE SEPARATED FROM THE DRILL EXTENSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25592548 ↗
• MalfunctionJun 23, 2026Mechanical Problem

  IT WAS REPORTED THAT THERE WAS A TOOL MALFUNCTION WHERE THE HEAD OF THE TOOL IS WORN OUT AND CANNOT BE CONNECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25592445 ↗
• MalfunctionJun 10, 2026Mechanical Problem

  IT WAS REPORTED THAT THERE WAS A TOOL MALFUNCTION WHERE THE HANDLE OF THE SURGICAL SCREWDRIVER GOT STUCK WITH THE DRIVER AND COULD NOT BE REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25455346 ↗
• MalfunctionMar 26, 2026Mechanical Problem

  IT WAS REPORTED THAT THE IMPLANT DRIVER GOT STUCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24697309 ↗
• MalfunctionMar 7, 2026Fracture

  CUSTOMER REPORTE 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 24540479 ↗
• MalfunctionFeb 20, 2026Mechanical Problem

  IT WAS REPORTED THAT THE IMPLANT DRIVER DOES NOT PICK UP THE IMPLANTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24402478 ↗
• MalfunctionFeb 11, 2026Fracture

  FRACTURE OF THE IMPLANT HOLDER DURING EXTRACTION. ADDITIONAL PART(S): IMPLANT HOLDER. ¿THE IMPLANT HOLDER BROKE DURING THE EXPLANTATION.¿ IMPLANT REF (B)(4). IMPLANT-HOLDER REF (B)(4). (B)(6) 2026, AO: IMPLANT LOSS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24317320 ↗