RESTORE 232015Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886705010950), received between Jul 22, 2019 and Jul 22, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 22, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT POST TO AN ACL PROCEDURE DURING THE STERILIZATION PROCESS IT WAS NOTICED THAT BITS OF TISSUE ARE GETTING STUCK IN THE CENTER OF THE CUSTOMER'S GRAFT SIZER BLOCK. THE SALES REP STATED THAT THE DEVICE IS DETERIORATING AND IS COARSE. THE CUSTOMER HAS STERILITY CONCERNS. THE PROCEDURE HAD BEEN COMPLETED WITH THE DEVICE BEFORE THE ISSUE WAS FOUND. THERE WAS NO PATIENT HARM OR SURGICAL DELAY TO THE CASE. THE SALES REP COULD NOT PROVIDE A LOT NUMBER FOR THE DEVICE BUT STATED THAT THE DEVICE IS AN OLDER DEVICE AND HAS SEEN HEAVY USED IN THE FIELD. THE DEVICE WILL BE RETURNING FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8812714 ↗