Equinoxe® 322-42-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10885862593917), received between Sep 13, 2024 and Jan 14, 2026 — classified as 5 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Aug 15, 2025Class IIOpen, Classified

   Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.

   Z-2562-2025 · Root cause: Process design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJan 14, 2026Naturally Worn

  IT WAS REPORTED A PATIENT UNDERWENT A LEFT TOTAL SHOULDER ARTHROPLASTY. SUBSEQUENTLY, ONE (1) YEAR AND 3(THREE) MONTHS LATER, THE PATIENT EXPERIENCED PAIN, A FALL, AND WAS DIAGNOSED WITH AN INFECTION. AS A RESULT, THE PATIENT UNDERWENT A SURGERY WHERE ALL IMPLANTS WERE EXPLANTED AND A SPACER WAS USED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 24071093 ↗
• InjuryAug 5, 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 HIS 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 22715423 ↗
• InjuryMay 8, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED, APPROXIMATELY 3 YEARS POST THE PREVIOUS LEFT SHOULDER SURGERY, THE PATIENT PRESENTED TO THE SURGEON'S PRIOR TO SURGERY WITH A DISLOCATED SHOULDER. IN SITU HUMERAL LINER WAS REMOVED AND THE SURGEON TRIALED WITH A THICKER HUMERAL LINER TRIAL. UPON DETERMINING THAT THE THICKER LINER PROVIDED THE STABILITY DESIRED, THE SURGEON IMPLANTED THE THICKER LINER. 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: Joint Dislocation

  MAUDE report 21984699 ↗
• InjuryOct 10, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED, APPROXIMATELY 3 MONTHS AND 6 DAYS POST THE PATIENT'S FIRST REVISION, THE PATIENT UNDERWENT A SECOND RIGHT SIDE SHOULDER REVISION DUE TO DISLOCATION. THE SURGEON CHANGED OUT THE LINER FROM A 42+0 TO A 42+2.5 CONSTRAINED. 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. FIRST REVISION REPORTED UNDER 1038671-2024-03432.

  Patient problems: Joint Dislocation

  MAUDE report 20416150 ↗
• InjurySep 13, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THIS PATIENT'S LEFT SHOULDER WAS REVISED 5 MONTHS POST OP. PATIENT EXPERIENCED EXTREME PAIN IN THE AFFECTED SHOULDER. PATIENT'S SHOULDER WAS UNSTABLE. THERE WAS AN AUDIBLE CLICKING WHEN MOVING ARM. THE MOVEMENT FELT MECHANICAL, NO LONGER NATURAL. THE CT REVEALED THAT THE POLYETHYLENE HUMERAL TRAY HAD BROKEN AND DISLODGED, CAUSING THE SHOULDER TO DISLOCATE.

  Patient problems: Pain

  MAUDE report 20212748 ↗