RESTORE 219337Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886705005826), received between Aug 10, 2023 and Feb 17, 2026 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 17, 2026Mechanical Jam

  IT WAS REPORTED THAT THE RESTORE ACORNREAM 7MM THIN DEVICE WAS STUCK ON THE CHUCK DEVICE. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24366893 ↗
• MalfunctionSep 15, 2024Inaccurate Information; Inaccurate Information

  THIS IS REPORT 3 OF 10 FOR (B)(4). IT WAS REPORTED FROM CHINA THAT THE LOT NUMBER ON THE LABEL ON THE RESTORE ACORNREAM 7MM 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 20220903 ↗
• MalfunctionAug 10, 2023Degraded; Degraded

  THIS IS REPORT 2 OF 6 FOR (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN AUSTRALIA THAT THE RESTORE ACORNREAM 7MM 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 17498770 ↗
• MalfunctionAug 10, 2023Degraded; Degraded

  THIS IS REPORT 4 OF 6 FOR (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN AUSTRALIA THAT THE RESTORE ACORNREAM 7MM 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 17498767 ↗
• MalfunctionAug 10, 2023Degraded; Degraded

  THIS IS REPORT 6 OF 6 FOR (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN AUSTRALIA THAT THE RESTORE ACORNREAM 7MM 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 17498765 ↗