Equinoxe 313-05-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862252203), received between Apr 18, 2022 and Apr 18, 2022 — 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• InjuryApr 18, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED FROM OUS THAT DURING AN ORTHOPEDIC SURGICAL PROCEDURE A DOWL PIN DISASSEMBLED FROM THE RESURFACING CAGE TAMP SHAFT. THE SURGEON HAD A RESURFACING, AFTER USING THE TAMP FOR THE CAGE IT WAS NOTED THAT THE LOCKING CATCH WAS NOT THERE, AND THE INSTRUMENT KEPT DETACHING AS A RESULT. THE SURGEON USED A PIN TO PLACE IN THE HOLE WHERE THE CATCH WOULD BE TO BE ABLE TO REMOVE THE TAMP FROM THE PATIENT. THE PATIENT REQUIRED X RAY TO DETERMINE WHETHER THE MISSING LOCK ON THE INSTRUMENT CAME DETACHED WHILST IN THE PATIENT, THERE WAS NOTHING FOUND ON THE X RAY AND THE SURGEON WAS SATISFIED THAT THE MISSING CATCH WAS NOT IN THE PATIENT. THERE WAS A DELAY TO SURGERY WITH NO PATIENT ADVERSE EVENT. THE AGENT WAS PRESENT AT THE TIME OF SURGERY. MULTIPLE EMAIL REQUESTS WERE SENT TO THE CONTACTS FOR ADDITIONAL INFORMATION. NO FURTHER INFORMATION HAS BEEN PROVIDED BY THE CONTACTS RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14135499 ↗