Equinoxe 321-35-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862594150), received between May 15, 2024 and May 15, 2024 — 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2024Break; Break

  AS REPORTED, THE SURGEON WAS IMPACTING THE BASEPLATE AND WENT TO REMOVE THE INSERTER TO CHECK THAT IT WAS FULLY SEATED AND THE SMALL BASEPLATE INSERTER TIP CAME APART. FRAGMENTS/PARTS/PIECES FELL INTO THE PATIENT WOUND SITE AND WERE REMOVED, AND THE SURGEON AND PA BOTH CONFIRMED THAT NO PIECES REMAINED WITHIN. THERE WAS A SURGICAL DELAY/PROLONGATION OF AN UNKNOWN AMOUNT OF TIME TO CHECK FOR PIECES AND SWITCH THE TO THE LINER INSERTER TO FURTHER SEAT THE BASEPLATE. THERE WERE NO ADVERSE EVENTS AS A RESULT. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19319000 ↗