RESTORE 219340Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10886705005857), received between Dec 6, 2019 and Feb 6, 2026 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Degraded” (10 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 6, 2026Degraded

  IT WAS REPORTED THAT DURING AN UNKNOWN KNEE PROCEDURE, THE RESTORE FULLFLUTE REAM 10MM DEVICE WAS DULL AND WE HAD TO USE THE 10 FEMUR BIT TO PERFORM THE TIBIAL TUNNEL THUS ACHIEVING TO FINISH THE SURGERY SUCCESSFULLY WITHOUT DISCOMFORT. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24283051 ↗
• MalfunctionFeb 24, 2025Degraded; Degraded

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT REPAIR SURGERY, IT WAS OBSERVED THAT THE RESTORE FULLFLUTE REAM 10MM DEVICE WAS EXTREMELY DULL. THERE WAS A SLIGHT UNSPECIFIED DELAY IN THE PROCEDURE REPORTED AS IT TOOK LONGER TO USE THE DEVICE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21444768 ↗
• MalfunctionSep 15, 2024Inaccurate Information; Inaccurate Information

  THIS IS REPORT 4 OF 5 FOR (B)(4). IT WAS REPORTED FROM CHINA THAT THE LOT NUMBER ON THE LABEL ON THE RESTORE FULLFLUTE REAM 10MM 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 20220931 ↗
• MalfunctionFeb 16, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  THIS IS REPORT 1 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 10MM, 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 16386071 ↗
• MalfunctionSep 7, 2022Degraded; Illegible Information; Degraded; Illegible Information

  THIS IS REPORT 1 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 15374014 ↗
• MalfunctionAug 3, 2022Degraded; Degraded

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE FULLY FLUTED REAMER DEVICE WAS DULL. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 15156697 ↗
• MalfunctionNov 22, 2021Degraded; Degraded

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE RESTORE FULLFLUTE REAM 10MM DEVICE WERE ROUNDED AND NOT CUTTING ANYMORE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 12856829 ↗
• MalfunctionNov 22, 2021Degraded; Degraded

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE RESTORE FULLFLUTE REAM 10MM DEVICE WERE ROUNDED AND NOT CUTTING ANYMORE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 12856818 ↗
• MalfunctionOct 11, 2021Degraded; Degraded

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE RESTORE FULLFLUTE REAM 10MM DEVICE WAS DULL. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF FIVE MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12605471 ↗
• MalfunctionMay 27, 2021Degraded; Degraded

  IT WAS REPORTED BY THE SALES REP THAT THE RESTORE FULLFLUTE REAM 10MM 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 11895823 ↗
• MalfunctionMay 27, 2021Degraded; Degraded

  IT WAS REPORTED BY THE SALES REP THAT THE RESTORE FULLFLUTE REAM 10MM 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 11895674 ↗
• MalfunctionMay 20, 2021Degraded; Degraded

  IT WAS REPORTED BY SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE RESTORE FULLFLUTE REAM 10MM EA DEVICE HAD BECOME DULL THAT IT DID NOT CUT VERY WELL. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WAS NO SURGICAL DELAY NOR PATIENT ADVERSE CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11858196 ↗
• MalfunctionNov 6, 2020Dull, Blunt; Dull, Blunt

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT THE FULLY FLUTED REAMER WAS DULL. NO PATIENT CONSEQUENCES. SLIGHT DELAY REPORTED. THE DEVICE IS AVAILABLE FOR EVALUATION.

  Patient problems: Not Applicable

  MAUDE report 10801959 ↗
• 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 9913202 ↗
• MalfunctionDec 17, 2019Dull, Blunt; Dull, Blunt

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE RESTORE FULLFLUTE REAM 10MM *EA WAS DULL THAT IT WAS VERY HARD TO CREATE THE HOLES IN THE BONE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE WAS WORN WITH HEAVY USE THAT ITS LASER MARKINGS WERE SLIGHTLY FADED. THERE WAS NO DELAY IN THE SURGICAL PROCEDURE. THERE WAS A SPARE DEVICE AVAILABLE FOR USE TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9481421 ↗
• 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 9433474 ↗