Equinoxe 321-14-00Recalls & reported problems
Exactech, Inc. · HUMERAL TRAY TRIAL +0 · Class 1
All models of Equinoxe (305)
Data updated Oct 16, 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 10885862580658), received between Jul 21, 2022 and Feb 16, 2023 — classified as 1 injury, 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 16, 2026.
Most reported problems
Device problems
- Break1
- Detachment of Device or Device Component1
- Misassembled During Installation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryFeb 16, 2023Detachment of Device or Device Component; Misassembled During Installation; Detachment of Device or Device Component; Misassembled During Installation
IT WAS REPORTED THAT DURING TRIALING THE TRAY DURING AN IMPLANT PROCEDURE, THE WASHER CAME OUT OF THE TRAY TRIAL AND THE SCREW CAME LOOSE. ALL PARTS WERE FOUND. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE SCREW AND TRAY ARE BEING RETURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16393286 ↗MalfunctionJul 21, 2022Break; Break
IT WAS REPORTED THAT THE RETAINING RING POPPED OUT DURING SURGERY. THERE WAS NO HARM TO THE PATIENT. NO OTHER INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15078649 ↗
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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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