EXACT REVERSE FP FULL TOOTH RASP SSI005614Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889024584914), received between Mar 23, 2020 and Mar 23, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 23, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9865970 ↗
• MalfunctionMar 23, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A RASP INSTRUMENT FOR SIZE 13 WAS ETCHED FOR SIZE 14 AND VICE VERSA. THERE IS NO KNOWN HARM OR INJURY TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9865960 ↗
• MalfunctionMar 23, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9865954 ↗