HALL® 00507125500Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20845854046019), received between Mar 31, 2023 and Mar 31, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (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.

• MalfunctionMar 31, 2023Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE 00507125500, OSCILLATOR BLADE, COATED, 25 X 100 X 1.19 MM, 5PK, WAS BEING USED DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023 WHEN IT WAS REPORTED, ¿TOOTH CHIPPED OFF THE BLADE. X-RAY WAS USED TO VERIFY NO METAL PIECES WERE LEFT IN THE JOINT.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT OR USER. FURTHER ASSESSMENT QUESTIONS WERE ASKED; HOWEVER, NO RESPONSE HAS BEEN RECEIVED TO DATE. AN X-RAY WAS TAKEN TO ASSURE NO METAL WAS LEFT IN THE PATIENT AND WE HAVE RECEIVED NO REPORT OF FRAGMENTATION BEING IN THE PATIENT. 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 16654297 ↗