Equinoxe 321-42-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862087911), received between Mar 23, 2022 and Mar 23, 2022 — classified as 1 injury.

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

Recent adverse event reports

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

• InjuryMar 23, 2022Break; Break

  IT WAS REPORTED THAT DURING REMOVAL/WITHDRAWAL, THE 42MM TRIAL LINER WAS REMOVED FROM THE MALE PATIENT'S RIGHT SHOULDER AFTER TRAILING AND SOME RESIDUAL YELLOW PARTICLES WERE LEFT IN THE PATIENT. THE YELLOW RESIDUAL WAS ONLY FOUND ON THE ADAPTER TRAY. THE SURGEON USED A SMALL FORCEPS AND FLUID TO REMOVE THE PIECES. THE SURGICAL SITE WAS CLEAN CLOSE UP. THERE WAS NO SURGICAL DELAY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE IS RETURNING FOR EVALUATION. REVISION STATED IN EXPERIENCE REPORT WAS CAPTURED UNDER 1038671-2022-00200 / CASE- (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 13859184 ↗