RESTORE 219349Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10886705005925), received between Dec 6, 2019 and Sep 19, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Degraded” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 19, 2025Degraded; Overheating of Device; Degraded; Overheating of Device

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE RESTORE FULLFLUTE REAM 9MM EA DEVICE SCREW DRIVE HANDLE RACHE DID NOT WORK. THE NINE-TIBIA BIT HAD NO EDGE WHICH GENERATED OVERHEATING OF THE BONE AND HANDPIECE. THE DEVICE WAS USED WITH THE ASMBLY, RATCHET HANDLE, QUICK DISCONNECT DEVICE. THERE WERE NO REPORTS OF DELAYS IN THE PROCEDURE REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23095267 ↗
• MalfunctionSep 15, 2024Inaccurate Information; Inaccurate Information

  THIS IS REPORT 6 OF 10 FOR (B)(4). IT WAS REPORTED FROM CHINA THAT THE LOT NUMBER ON THE LABEL ON THE RESTORE FULLFLUTE REAM 9MM DEVICE WAS NOT CONSISTENT WITH THE LOT NUMBER THAT WAS ETCHED ON IT. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20220906 ↗
• MalfunctionJul 3, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED BY THE AFFILIATE IN COLOMBIA THAT DURING AN UNKNOWN PROCEDURE ON (B)(6)2023, IT WAS OBSERVED THAT THE FULLY FLUTED REAMER DEVICE ARRIVED DIRTY OF BONE. IT WAS UNKNOWN IF AND HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17251366 ↗
• MalfunctionMay 30, 2023Degraded; Use of Device Problem; Degraded; Use of Device Problem

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN COLOMBIA THAT THE TIP ON THE FULLY FLUTED REAMER DEVICE WAS DAMAGED. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE TIP WAS DULL. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17023033 ↗
• MalfunctionFeb 16, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  THIS IS REPORT 2 OF 15 FOR (B)(4). IT WAS REPORTED BY THE FIELD SERVICE ENGINEER THAT DURING INSPECTION, THE CUSTOMER OBSERVED THAT THE RESTORE FULLY FLUTED REAMER 7MM, 40-130MM (PLUS OR MINUS 5 PERCENT) DEVICE HAD CONTAMINATION INSIDE ITS CANNULATED SECTION. ACCORDING TO THE REPORT, THE EVENT OCCURRED BEFORE PROCESSING WHEN THE CUSTOMER DECIDED TO INSPECT THE DEVICE WITH THEIR BORESCOPE. IT WAS REPORTED THAT THE DEVICE WAS PURCHASED ON JUNE 2022; AND HAS NEVER BEEN USED. IT WAS FURTHER REPORTED THAT THE DEVICE WAS SHELVED AND STORED IN CONTROLLED ENVIRONMENT IN THE STERILE PROCESSING DEPARTMENT. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16386070 ↗
• MalfunctionSep 7, 2022Degraded; Illegible Information; Degraded; Illegible Information

  THIS IS REPORT 4 OF 6 FOR (B)(4). IT WAS REPORTED BY SALES REP THAT THE FULLY FLUTED REAMER DEVICE WAS REALLY DULL AND NOT SHARP. IT WAS FURTHER REPORTED THAT THE LOT NUMBER COULD NO LONGER BE READ. THERE WAS NO PATIENT NOR PROCEDURE INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15374018 ↗
• MalfunctionMay 27, 2021Degraded; Degraded

  IT WAS REPORTED BY THE SALES REP THAT THE RESTORE FULLFLUTE REAM 9MM DEVICE WAS DULL. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11895916 ↗
• MalfunctionMay 27, 2021Degraded; Degraded

  IT WAS REPORTED BY THE SALES REP THAT THE RESTORE FULLFLUTE REAM 9MM DEVICE WAS DULL. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11895888 ↗
• MalfunctionApr 1, 2020Dull, Blunt; Dull, Blunt

  IT WAS REPORTED BY SALES REPRESENTATIVE VIA CONVENTIONS AND MEETINGS THAT BEFORE AN ANT.CRUCIATE LIGAMENT DECOMPRESSION PROCEDURE THE PHYSICIAN NOTICED THAT THE SIZE OF THE CRUCIATE+ RETROREAMER BULLET WAS TOO BIG AND WOULDN´T FIT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. AFTER THE PROCEDURE WAS FINISHED THE REP INSPECTED HIS PRODUCTS AND NOTICED THAT THE FOLLOWING DEVICES WERE DULL: FULLY FLUTED REAMER (6 MM, 6.5 MM, 7 MM, 7.5 MM, 8 MM, 8.5 MM, 9 MM, 9.5 MM, 10 MM, 10.5 MM, 11 MM, 11.5 MM, 12 MM). ALL DEVICES ARE AVAILABLE TO BE RETURNED FOR EVALUATION. THIS COMPLAINT IS RELATED TO (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9912459 ↗
• MalfunctionDec 6, 2019Dull, Blunt

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN ACL PROCEDURE THE SURGEON FOUND THAT THE SALES REP'S RESTORE FULL FLUTE REAMER 7MM, RESTORE FULL FLUTE REAMER 7.5MM, RESTORE FULL FLUTE REAMER 8MM, RESTORE FULL FLUTE REAMER 8.5MM, RESTORE FULL FLUTE REAMER 9MM, RESTORE FULL FLUTE REAMER 9.5MM, AND RESTORE FULL FLUTE REAMER 10MM ARE ALL DULL. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE DEVICES WITH NO PATIENT HARM OR SURGICAL DELAY TO THE CASE. THE SALES REP WAS NOT PRESENT FOR THE CASE THEREFORE COULD NOT PROVIDE ANY FURTHER INFORMATION OR LOT NUMBERS FOR THE DEVICES. THE DEVICES WILL BE RETURNING FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9433498 ↗