Equinoxe 321-00-12Recalls & reported problems
Exactech, Inc. · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862541260), received between May 14, 2021 and May 14, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (1 report).
1 FDA recall record name this device's identifier.
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.
Recalls naming this device
- May 11, 2021Completed
The HAT trial contains a retaining ring that has shown the potential to disengage during use.
Z-1977-2021 · Root cause: Device Design · FDA record ↗
Most reported problems
Device problems
- Break1
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.
InjuryMay 14, 2021Break; Break
AS REPORTED, DURING THE PROCEDURE, THE +0 LATERALIZED TRAY THREADED ONTO THE FRACTURE STEM DURING TRAILING. DURING REMOVAL, THE RETAINING RING INSIDE THE TRIAL POPPED OFF AND FELL INTO THE PATIENT WOUND SITE. THE RETAINING RING WAS FOUND AND REMOVED FROM THE PATIENT WOUND SITE, BUT THE SURGEON COULD NOT RE-THREAD THE TRAIL WITHOUT THE RETAINING RING. THE SURGEON THEN TRAILED +5 LATERALIZED TRIAL AND WHEN TRYING TO THREAD TRIAL ONTO STEM THE RETAINING RING AGAIN POPPED OFF AND WOULD NOT THREAD ONTO TRIAL. THE SURGEON DECIDED TO STOP USING THE HAT SYSTEM AND USED FRACTURE STEM INSTEAD. ALL PARTS WERE RETRIEVED FROM THE PATIENT WOUND SITE AND WERE ACCOUNTED FOR. THERE WAS A 5-15 MINUTE DELAY AND THERE WERE NO ADVERSE EVENT RESULTING FORM THE DELAY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE ARE RETURNING FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11828850 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.