RESTORE 219303Recalls & reported problems
Medos International Sàrl · RESTORE OSTEOTOME WITH MM SCALE 5mm · Class 1
All models of RESTORE (33)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886705005581), received between Jan 16, 2019 and Oct 28, 2021 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (2 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
Device problems
- Break2
- Device Contamination with Chemical or Other Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Not Applicable1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 28, 2021Break; Break
IT WAS REPORTED BY THE SALES REP THAT DURING THE ROUTINE PROCESSING AND STERILIZATION FROM WEAR AND TEAR, IT WAS OBSERVED THAT THE NCHPLSTY OSTEOTOME W/SCALE DEVICE WAS BROKEN. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12713175 ↗MalfunctionOct 28, 2021Break; Break
IT WAS REPORTED BY THE SALES REP THAT DURING THE ROUTINE PROCESSING AND STERILIZATION FROM WEAR AND TEAR, IT WAS OBSERVED THAT THE NCHPLSTY OSTEOTOME W/SCALE DEVICE WAS BROKEN. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12713133 ↗MalfunctionJan 16, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT IT LOOKS LIKE SOME PLASTIC MATERIAL WAS LEFT INSIDE TRAY CONTAINER AND MELTED IN A SMALL POOL AT THE BOTTOM OF THE TRAY WHEN IT WAS AUTOCLAVED. THERE WAS NO PATIENT CONSEQUENCE. ALL THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT.
Patient problems: Not Applicable
MAUDE report 8253180 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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