Equinoxe 320-08-46Recalls & reported problems
Exactech, Inc. · Class 2 · Implant
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862563743), received between Dec 22, 2025 and Dec 22, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment of Device or Device 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
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.
InjuryDec 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT A MALE PATIENT, WHO HAD A RIGHT RTSA, UNDERWENT A REVISION PROCEDURE. THE LOCKING SCREW CAME OUT OF THE SPHERE. THE SPHERE, TRAY, POLY, AND LOCKING SCREW WERE REVISED WITH NEW IMPLANTS. THERE WERE NO DEVICE BREAKAGES DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. AN X-RAY WAS PROVIDED. THE EXPLANTED DEVICE IS NOT AVAILABLE FOR RETURN DUE TO HOSPITAL POLICIES. NO FURTHER INFORMATION THI IS 1 OF 3 REPORTS FOR THIS EVENT. THIS IS 1 OF 2 EVENTS FOR THIS PATIENT.
Patient problems: Insufficient Information
MAUDE report 23871047 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.