Equinoxe® 322-10-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862606952), received between Jul 11, 2025 and Aug 14, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 14, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED IN A SHOULDER CLINICAL STUDY THAT APPROXIMATELY 8 MONTHS AFTER UNDERGOING A RIGHT REVERSE TOTAL SHOULDER REPLACEMENT, THE PATIENT EXPERIENCED POPPING IN THE RIGHT SHOULDER FOR A COUPLE OF MONTHS. SUBSEQUENTLY THE PATIENT WAS DIAGNOSED WITH DISASSOCIATION OF POLYETHYLENE COMPONENT. IT WAS REPORTED THE PATIENT WILL UNDERGO A REVISION OF THE RIGHT SHOULDER. DATE OF THE REVISION IS UNKNOWN OR UNSCHEDULED AT THE TIME OF REPORTING. THE PATIENT'S OUTCOME WAS REPORTED AS CONTINUING. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Musculoskeletal problem

  MAUDE report 22810930 ↗
• InjuryJul 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE PATIENT UNDERWENT AN INITIAL LEFT REVERSE TOTAL SHOULDER ARTHROPLASTY APPROXIMATELY 3 MONTHS AGO. THE PATIENT COMPLAINED OF PAIN AND WAS REVISED DUE TO POLY DISASSOCIATION. 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: Pain

  MAUDE report 22480034 ↗

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