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RESTORE 219551Recalls & reported problems

Medos International Sàrl · RESTORE ACORN REAMER/THIN SHAFT 10.5mm (Plus or Minus 10 Percent) · Class 1

All models of RESTORE (33)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886705006724), received between Sep 7, 2022 and Sep 7, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Degraded” (1 report).

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

Device problems

  • Degraded1
  • Illegible Information1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 7, 2022Degraded; Illegible Information; Degraded; Illegible Information

    THIS IS REPORT 3 OF 6 FOR (B)(4). IT WAS REPORTED BY SALES REP THAT THE 10.5MM ACORN 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 15374011 ↗

Other REAMER devices

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Sources and updates

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