Equinoxe 315-35-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862085658), received between May 13, 2021 and Nov 29, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 29, 2022Break; Fracture; Break; Fracture

  AS REPORTED, DURING SURGICAL PROCEDURE THE 2.0MM K-WIRE FRACTURED DURING GLENOID REAMING WITH 38MM CANNULATED REAMER. APPROX. 1.5CM OF THE DISTAL TIP FRACTURED. FRACTURED TIP WAS UNABLE TO BE RETRIEVED. STANDARD GLENOID BASED PLATE INSERTED WITHOUT ISSUE. THE REVERSE TOTAL SHOULDER PROCEDURE CONTINUED WITHOUT INCIDENT. ALL GLENOID COMPONENTS (GLENOID BASEPLATE/SCREWS / GLENOSPHERE) IMPLANTED WITHOUT ISSUE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED. DEVICE IS NOT RETURNING, SENT TO PATHOLOGY AT HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15879638 ↗
• InjuryMay 13, 2021Break; Break

  DURING A TOTAL SHOULDER ARTHROPLASTY ON THIS (B)(6) Y/O MALE PATIENT, THE SURGEON INSERTED 2.0 GUIDE WIRE AND PLACED THE GLENOID REAMER OVER GUIDE WIRE. WHILE REAMING, THE GUIDE WIRE BROKE AND PART OF IT WAS STILL IN GLENOID. HE WAS ABLE TO SAFELY REMOVE THE PIECE THAT WAS IN PATIENT. PATIENT WAS NOT AFFECTED SURGERY WENT FINE. THE DEVICE WAS ACCIDENTALLY DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11816166 ↗