30Ncm Torque Wrench TW30Recalls & reported problems
Implant Direct Sybron Manufacturing LLC · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10841307119241), received between Dec 20, 2019 and Oct 4, 2022 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Defective Component” (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 18, 2026.
Most reported problems
Device problems
- Defective Component1
- Fracture1
Patient problems
- Failure of Implant1
- No Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 4, 2022Fracture; Fracture
PER COMPLAINT (B)(4), DURING CLINCIAL PROCEDURE, TORQUE WRENCH IS NOT WORKING CORRECTLY.
Patient problems: Failure of Implant
MAUDE report 15536461 ↗MalfunctionDec 20, 2019Defective Component; Defective Component
AS PER COMPLAINT (B)(4), THE DOCTOR STATED THAT THE DENTAL TOOL WILL NOT ENGAGE WITH A DENTAL TOOL FITTING.
Patient problems: No Information
MAUDE report 9500949 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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