RESTORE 219550Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886705006717), received between Oct 17, 2022 and May 11, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Illegible Information” (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 16, 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.

• MalfunctionMay 11, 2026Material Deformation

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE SHAFT OF THE RESTORE DEVICE WAS BENT, CAUSING IT TO WOBBLE WHEN ROTATED. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25138120 ↗
• MalfunctionOct 17, 2022Illegible Information; Illegible Information

  IT WAS REPORTED BY THE SALES REP THAT THE RESTORE ACORNREAM 9.5MM THIN *EA DEVICE HAD ILLEGIBLE ETCH (FADED). DURING AN IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE WOULD NOT CUT/DULL. THERE WAS NO PROCEDURE INVOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15619332 ↗