NA 389.393Recalls & reported problems
Synthes (U.S.A.) LP · BONE CURETTE - ANGLED HEAD 5.5MM X 8.25MM/250MM LENGTH · Class 1
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 10705034775593), received between Sep 12, 2023 and Sep 12, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Integrity Problem” (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
- Material Integrity Problem1
- No Apparent Adverse Event1
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 12, 2023Material Integrity Problem; No Apparent Adverse Event; Material Integrity Problem; No Apparent Adverse Event
IT WAS REPORTED ON AN UNKNOWN DATE, THAT THE BENDER BROKE. THERE WAS NO PATIENT OUTCOMES REPORTED. THIS REPORT IS FOR ONE (1) BONECURETTE ANGL OVAL EDGE 5.5*8.25 L480 THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17731964 ↗
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- Centurion 66745Centurion Medical Products Corporation · CURETTE1 recall0 reports
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- Centurion 67430Centurion Medical Products Corporation · CURETTE1 recall0 reports
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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