Equinoxe 531-55-26Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862578198), received between Oct 25, 2024 and Oct 25, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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.

• MalfunctionOct 25, 2024Fracture; Separation Failure; Fracture; Separation Failure

  IT WAS REPORTED THAT DURING A SHOULDER PROCEDURE, A 3.2 PIN WAS DEFORMED DUE TO A HARD GLENOID BONE AND COULD NOT COME BACK THOUGH THE GUIDE. WHEN FORCED BY POWER, IT BECAME LODGED IN CANNULATION. THERE WAS A BREAKAGE OF DEVICE, BUT NO FRAGMENTS, PARTS, OR PIECES FELL INTO THE WOUND OR THE PATIENT. THERE WAS A SURGICAL DELAY REPORTED WITH NO ADVERSE EVENT TO THE PATIENT. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE IS AVAILABLE FOR RETURN. AN IMAGE OF THE DEVICE WAS PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 20536156 ↗

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