NA 03.816.003Recalls & reported problems
Synthes GmbH · BLADE HOLDER-RIGHT · Class 1
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 10705034730646), received between Oct 11, 2024 and Sep 30, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Compatibility Problem” (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.
Reports received per month
Most reported problems
Device problems
- Compatibility Problem3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Compatibility Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951503 ↗MalfunctionMar 3, 2025Compatibility Problem; Compatibility Problem
IT WAS REPORTED THAT THE BLADE HOLDER CANNOT BE INSERTED INTO THE RETRACTOR. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21504543 ↗MalfunctionOct 11, 2024Compatibility Problem; Compatibility Problem
ADDITIONAL INFORMATION RECEIVED STATES THAT ON 10/29/2024, IT WAS DISCOVERED THAT THE DEVICE (BLADE L120) WAS SCRATCHED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20427504 ↗
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- Omni-Tract® 4040Integra Lifesciences Corporation · RETRACTOR1 recall3 reports
- RadiaLux™ 50-101-1Medtronic Navigation, Inc. · RETRACTOR1 recall2 reports
- Omni-Tract® 11275Integra Lifesciences Corporation · RETRACTOR1 recall2 reports
- CHARNLEY 9620-04-000Depuy International Ltd · RETRACTOR1 recall2 reports
- NA 2176-10-000Depuy (Ireland) · RETRACTOR51 reports
- Fathom MR2-102050Seaspine Orthopedics Corporation · RETRACTOR1 recall1 report
- Omni-Tract® 3104RIntegra Lifesciences Corporation · RETRACTOR1 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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