Equinoxe® 322-10-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862593771), received between May 8, 2025 and May 8, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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 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.

• InjuryMay 8, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED, FOLLOWING THE PREVIOUS LEFT SHOULDER REVISION, THE PATIENT DISLOCATED A MONTH LATER AND WAS REVISED AGAIN TO A 42 +4 AND 5 TRAY AND 42 +2.5 POLY. THE SHOULDER HAS DONE FINE SINCE. 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 21984868 ↗

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