Equinoxe 317-21-05Recalls & reported problems
Exactech, Inc. · KLIMO FUKUDA RETRACTOR · Class 1
All models of Equinoxe (305)
Data updated Oct 18, 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 10885862557568), received between Jul 1, 2022 and Jul 1, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 1, 2022Break; Break
IT WAS REPORTED FROM THE DIGITAL AND MARKETING COMMUNICATIONS SR. MANAGER, EXACTECH, THAT A SURGEON TAGGED EXACTECH IN AN INSTAGRAM POST. A PHYSICIANS ASSISTANT POSTED, "I SNAPPED STEEL IN HALF TODAY". A PICTURE OF THE PA HOLDING A RETRACTOR WITH THE T-HANDLE BROKEN FROM THE RETRACTOR BODY WAS SHOWN. NO FURTHER DETAILS PROVIDED. NO INDICATION OF ANY PATIENT IMPACT REPORTED.
Patient problems: Insufficient Information
MAUDE report 14884132 ↗
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- Omni-Tract® 11303RIntegra 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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