Astra Tech Implant System® 22192Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07392532000997), received between Mar 25, 2026 and Jun 3, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 3, 2026Mechanical Problem

  IT WAS REPORTED THAT THERE WAS A TOOL MALFUNCTION THE INSTRUMENT COULD NOT BE AFFIXED ONTO THE BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25372264 ↗
• InjuryMar 25, 2026Fracture

  IT WAS REPORTED THAT THE TRIANGULAR PART OF THE HEAD OF THE UNI ABUTMENT PEELED OFF, LEAVING ONLY THE FRAGMENT INSIDE THE IMPLANT. AN ATTEMPT WAS MADE TO REMOVE IT BY CREATING A DEPRESSION WITH A DIAMOND POINT AND USING THE PRODUCT IN QUESTION, BUT THE PRODUCT FRACTURED. A SECOND ATTEMPT WAS MADE WITH THE SAME PRODUCT, BUT IT FRACTURED AGAIN. FINALLY, THE REMAINING UNI ABUTMENT WAS REMOVED USING A DIAMOND POINT. THE IMPLANT IS STILL LOADABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24689823 ↗