RESTORE 219335Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886705005802), received between Jan 16, 2020 and Nov 29, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Degraded” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 29, 2024Degraded; Illegible Information; Degraded; Illegible Information

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT REPAIR SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE RESTORE ACORNREAM 10MM THIN DEVICE BLADE WAS DULL AND MEASUREMENTS WERE HARD TO READ AS THE DEVICE WAS USED ALOT. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20809355 ↗
• MalfunctionSep 15, 2024Inaccurate Information; Inaccurate Information

  THIS IS REPORT 3 OF 5 FOR (B)(4). IT WAS REPORTED FROM CHINA THAT THE LOT NUMBER ON THE LABEL ON THE RESTORE ACORNREAM 10MM THIN 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 20220930 ↗
• MalfunctionSep 7, 2022Degraded; Illegible Information; Degraded; Illegible Information

  THIS IS REPORT 2 OF 6 FOR (B)(4). IT WAS REPORTED BY SALES REP THAT THE ACORN REAMER THIN SHAFT 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 15374044 ↗
• MalfunctionJul 7, 2021Degraded; Degraded

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT ACORN REAMER THIN SHAFT DEVICE WAS DULL. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF 1-2 MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12128516 ↗
• MalfunctionFeb 28, 2020Dull, Blunt; Dull, Blunt

  THE SALES REP REPORTED VIA PHONE THAT THE CUSTOMER'S 8MM AND TWO OF THE 10 MM ACORN REAMER THIN ARE DULL THEREFORE COULD NOT BE USED FOR AN ACL PROCEDURE. THE CASE WAS COMPLETED WITH ANOTHER LIKE DEVICE. THE SALES REP WAS NOT PRESENT FOR THE CASE BUT REPORTED NO ADVERSE PATIENT CONSEQUENCES OR DELAY. THE DEVICES WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9771136 ↗
• MalfunctionFeb 28, 2020Dull, Blunt; Dull, Blunt

  THE SALES REP REPORTED VIA PHONE THAT THE CUSTOMER'S 8MM AND TWO OF THE 10 MM ACORN REAMER THIN ARE DULL THEREFORE COULD NOT BE USED FOR AN ACL PROCEDURE. THE CASE WAS COMPLETED WITH ANOTHER LIKE DEVICE. THE SALES REP WAS NOT PRESENT FOR THE CASE BUT REPORTED NO ADVERSE PATIENT CONSEQUENCES OR DELAY. THE DEVICES WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9771030 ↗
• MalfunctionJan 16, 2020Dull, Blunt; Dull, Blunt

  IT WAS REPORTED BY THE SALES REP VIA EMAIL THAT DURING AN ACL PROCEDURE IT WAS FOUND THAT THEIR ACORN REAMER 10 MM IS DULL. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIKE DEVICE WITH NO PATIENT HARM OR SURGICAL DELAY TO THE CASE. THE SALES REP COULD NOT PROVIDE A LOT NUMBER FOR THE DEVICE. THE DEVICE WILL BE RETURNING FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9598424 ↗