Equinoxe 531-55-64Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862583185), received between Jan 24, 2025 and Jan 24, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

1 other recall cover devices cleared under the same FDA submission (K162567); they may or may not involve this specific model.

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.

• InjuryJan 24, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL SHOULDER REPLACEMENT PROCEDURE. AFTER USING NAVIGATION TO LOCATE THE STARTING POINT FOR DRILLING THE PATIENT'S BONE FOR PLACEMENT OF THE GLENOID CAGE COMPONENT, IT WAS NOTED THAT THE PATIENT'S GLENOID BONE FRACTURED. THE FRACTURE WAS TREATED BY FILLING THE SPACE WITH BONE GRAFT AND THE SURGEON DRILLED A NEW HOLE FOR PLACEMENT OF THE CAGE TO COMPLETE THE PROCEDURE. FOLLOWING PLACEMENT, IT WAS NOTED THAT THE IMPLANT MAY HAVE BEEN PLACED A LITTLE HIGHER THAN PREFERRED. IT IS UNKNOWN HOW THE PATIENT IS DOING POST-OP.

  Patient problems: Bone Fracture(s)

  MAUDE report 21235873 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K162567. One submission often covers many models, so check the product and lot details in each record.

• Z-0603-2018 · Jul 11, 2017 · Terminated
  Exactech GPS Total Shoulder Application 3.2mm Vix Bit Orthopedic surgical tool