RESTORE 219308Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886705005635), received between Aug 22, 2018 and Oct 25, 2019 — classified as 2 malfunctions.

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

• MalfunctionOct 25, 2019Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING A SHOULDER SCOPE PROCEDURE IT WAS FOUND THAT THE RESTORE CUP CURETTE IS DULL AND NOT WORKING PROPERLY. THE PROCEDURE WAS COMPLETED WITH A NON-MITEK DEVICE WITH NO PATIENT HARM OR SURGICAL DELAY TO THE CASE. THIS REPORT IS FOR A RESTORE CUP CURETTE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9238477 ↗
• MalfunctionAug 22, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP THAT THE HANDLE ON HIS CUP CURETTE BROKE IN HALF DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) SURGICAL PROCEDURE. IT WAS REPORTED THAT NOTHING FELL INSIDE THE PATIENT. THE SURGEON USED ANOTHER LIKE DEVICE TO COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCES OR DELAYS. THE SALES REP DID NOT HAVE A LOT NUMBER BUT VERIFIED THE DEVICE WAS OVER FIVE YEARS OLD. THE DEVICE WAS ALREADY DISCARDED BY THE CUSTOMER. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7804907 ↗