Equinoxe® 322-10-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885862593788), received between Aug 18, 2025 and Sep 18, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K223833); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2026Detachment of Device or Device Component

  Patient problems: Pain

  MAUDE report 50819643 ↗
• InjuryJul 31, 2026Detachment of Device or Device Component

  As reported, the patient underwent a reverse total shoulder arthroplasty. Subsequently, the patient was revised due to suspected humeral liner dissociation from the humeral adapter tray. It was confirmed intraoperatively that the patient's humeral liner had dissociated from the humeral adapter tray. There was no reported breakage of a device or surgical delay/prolongation. The patient was last known to be in stable condition following the event.

  Patient problems: Insufficient Information

  MAUDE report 50101842 ↗
• InjuryAug 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THIS PATIENT UNDERWENT AN INITIAL SHOULDER REPLACEMENT ON THE LEFT SIDE. SUBSEQUENTLY, THE PATIENT PRESENTED BACK TO SURGEON'S OFFICE. X RAYS SHOWED THAT THE HUMERAL TRY AND TORQUE DEFINING SCREW DISASSOCIATED FROM THE HUMERAL STEM. INTRA-OPERATIVE FINDINGS CONFIRMED THIS TO BE THE CASE, AS WELL AS DEMONSTRATING THAT HUMERAL LINER WAS DISSOCIATED FROM HUMERAL TRAY. THE THREADED PORTION OF THE TORQUE DEFINING SCREW, WHICH WAS REMOVED, WAS NOT BROKEN. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PATIENT PRESENTED TO SURGEON'S OFFICE. XRAY CONFIRMED THAT HUMERAL TRAY AND TORQUE-DEFINING SCREW WERE DISSOCIATED FROM HUMERAL STEM. INTRA-OPERATIVE FINDINGS CONFIRMED THIS TO BE THE CASE, AS WELL AS DEMONSTRATING THAT HUMERAL LINER WAS DISSOCIATED FROM HUMERAL TRAY. IT IS MY UNDERSTANDING THAT THE THREADED PORTION OF THE TORQUE DEFINING SCREW, WHICH WAS REMOVED, WAS NOT BROKEN. PLEASE DESCRIBE WHEN EVENT OCCURRED BELOW. SOMETIME PRIOR TO SURGERY. IT IS UNCLEAR WHETHER THE PATIENT EXPERIENCED A FALL LEADING TO THE ISSUES. IS THE REPORTED EVENT ASSOCIATED WITH REVISION OF EXACTECH IMPLANTS? YES. WHAT SIDE WAS AFFECTED? LEFT. INITIAL IMPLANT DATE (

  Patient problems: Insufficient Information

  MAUDE report 22835662 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K223833. One submission often covers many models, so check the product and lot details in each record.

• Z-2562-2025 · Aug 15, 2025 · Open, Classified
  Exactech Equinoxe, Reverse Shoulder Humeral Liners, 322-38-00 (145-DEG PE 38MM HUM LINER +0), REF: 322-38-03 (145-DEG PE 38MM HUM LINER +2.5), REF:322-42-00 (145-DEG PE 42MM HUM L