HALL MICROFREE PRO8200SBRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10653405005735), received between Nov 11, 2025 and Nov 11, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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. How this data works · Data updated Oct 13, 2026.

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.

• MalfunctionNov 11, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A DISTRIBUTOR REPORTED ON BEHALF OF A CUSTOMER THAT THE PRO8200SB, HALL MICROFREE SAGITTAL SAW DEVICE WAS USED IN AN UNKNOWN PROCEDURE ON (B)(6) 2025, AND ¿WHEN A SAGITTAL BLADE ¿ WAS ATTACHED TO THE MICROFREE SAGITTAL SAW TO PERFORM BONE CUTTING, THE BLADE EASILY CAME OFF.¿. THERE WAS NO INJURY TO THE PATIENT OR USER. THE PROCEDURE WAS COMPLETED WITHOUT THE USE OF AN ALTERNATE DEVICE AND NO REPORTED DELAY. FURTHER ASSESSMENT FOUND "THE BLADE IS NOT BROKEN, BUT IT HAS COME OFF THE HANDPIECE", FELL INTO THE SURGICAL SITE AND WAS RETRIEVED. THERE WAS NO REPORT OF MEDICAL/SURGICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23525833 ↗