Equinoxe 321-07-05Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862087140), received between Jun 15, 2023 and Jun 15, 2023 — 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. 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.

• MalfunctionJun 15, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ANATOMIC SHOULDER REPLACEMENT AT THE OAKS HOSPITAL, THE GLENOID WAS PREPARED AS PER OPERATIVE SURGICAL TECHNIQUE. WHEN CEMENTING THE GLENOID, THE IMPLANT WAS PLACED INTO CORRECT POSITION IN LINE WITH THE SURGICAL PLAN, THE SURGEON WAS USING THE IMPACTOR HANDLE WITH TIP ATTACHED TO PRESSURIZE THE IMPLANT WHILE WAITING FOR CEMENT TO SET. ONCE THE CEMENT HAD SET THE SURGEON HANDED THE IMPACTOR HANDLE BACK TO THE AGENCY SCRUB NURSE AND THE END OF THE IMPACTOR HANDLE HAD SHEARED OFF. NO PARTS OF THE INSTRUMENT LANDED WITHIN THE SURGICAL SITE, ALL PARTS WERE PUT TO ONE SIDE AND BOTH SURGEON AND SCRUB NURSE CHANGED THERE SURGICAL GLOVES TO CONTINUE THE PROCEDURE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO PATIENT/MEDICAL INFORMATION PROVIDED. IMAGES ATTACHED. UNABLE TO OBTAIN X-RAYS. PRODUCT IS AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17139600 ↗