CUSA® Clarity C7602EARecalls & reported problems
Integra Lifesciences (Ireland) Limited · CUSA® Clarity 36kHz Torque Wrench · Class U
All models of CUSA Clarity (21)
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 10381780126317), received between Jun 27, 2024 and Jun 27, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Use of Device 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.
Reports received per month
Most reported problems
Device problems
- Use of Device Problem1
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.
MalfunctionJun 27, 2024Use of Device Problem; Use of Device Problem
A FACILITY REPORTED THAT A SAMPLE CUSA CLARITY 36KHZ TORQUE WRENCH (SINGLE PACK) (C7602EA), CONTAMINATED THE CLEAN FIELD DURING BRAIN TUMOR SURGERY. THEY STATED THAT THE SALES REPRESENTATIVE BROUGHT THE SAMPLE TO THE FACILITY BY MISTAKE, AND THE NURSE NOTICED THE STICKER ON THE PRODUCT AND REPLACED THE PRODUCT WITH A NEW ONE. THERE WAS NO PATIENT INJURY AND NO SIGNIFICANT SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19624228 ↗
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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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