RESTORE 219338Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886705005833), received between Feb 28, 2020 and Sep 15, 2024 — classified as 7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2024Inaccurate Information; Inaccurate Information

  THIS IS REPORT 4 OF 10 FOR (B)(4). IT WAS REPORTED FROM CHINA THAT THE LOT NUMBER ON THE LABEL ON THE RESTORE ACORNREAM 8MM 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 20220912 ↗
• MalfunctionJun 4, 2024Degraded; Degraded

  IT WAS REPORTED THAT THE RESTORE ACORNREAM 8MM THIN DEVICE REAMER WAS BLUNT. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE, OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19458794 ↗
• MalfunctionAug 10, 2023Degraded; Degraded

  THIS IS REPORT 5 OF 6 FOR (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN AUSTRALIA THAT THE RESTORE ACORNREAM 8MM THIN EA DEVICE WAS BLUNT. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17498777 ↗
• MalfunctionAug 10, 2023Degraded; Degraded

  THIS IS REPORT 3 OF 6 FOR (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN AUSTRALIA THAT THE RESTORE ACORNREAM 8MM THIN EA DEVICE WAS BLUNT. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17498768 ↗
• MalfunctionAug 10, 2023Degraded; Degraded

  THIS IS REPORT 1 OF 6 FOR (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN AUSTRALIA THAT THE RESTORE ACORNREAM 8MM THIN *EA DEVICE WAS BLUNT. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17498766 ↗
• MalfunctionDec 18, 2020Degraded; Degraded

  IT WAS REPORTED BY THE AFFILIATE IN AUSTRALIA THAT DURING AN ANTERIOR CRUCIATE LIGAMENT PROCEDURE ON (B)(6) 2020, IT WAS OBSERVED THAT THE RESTORE ACORNREAM 8MM THIN SHAFT DEVICE WAS BLUNT AND THE SURGEON FOUND IT DIFFICULT TO REAM THROUGH BOTH TIBIA AND FEMUR. IT WAS REPORTED THAT THERE WAS NO SURGICAL DELAY OR PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11037451 ↗
• 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 9771115 ↗