Equinoxe 320-05-21Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862567772), received between Sep 25, 2023 and Sep 25, 2023 — 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 (K191561); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2023Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 75 YO MALE PATIENT WHO WAS ENROLLED IN AN EXACTECH SHOULDER CLINICAL STUDY ON (B)(6) 2022, RECEIVED EXACTECH DEVICES ON (B)(6) 2022, AFTER THEIR ANTIBIOTIC SPACER WAS REMOVED AND THE SHOULDER WAS IRRIGATED AND DEBRIDED. DATE OF INITIAL EXACTECH DEVICE(S)IMPLANTATION, AND PLACEMENT OF THE ANTIBIOTIC SPACER UNKNOWN. THEY WERE REVISED ON (B)(6) 2022, DUE TO INFECTION AND DISLOCATION OF THEIR REPLACEMENT. DATE OF ONSET, (B)(6) 2022. THE SURVEILLANCE CULTURES TESTED POSITIVE FOR STAPH EPIDERMIDIS. AFTER CONSULTATION WITH INFECTION DISEASE, HE WAS PLACED ON DOXYCYCLINE. X-RAYS SHOWED ANTERIOR DISLOCATION OF REPLACEMENT, THERE ALSO APPEARED TO BE DISPLACEMENT OF BONY FRAGMENT OF THE CALCAR REGION. THE TRAY, LINER, GLENOSPHERE, AND GLENOSPHERE SCREWS WERE REVISED. THE PATIENT¿S OUTCOME WAS LAST KNOWN AS RESOLVED. THE CASE REPORT FORM INDICATES THIS EVENT IS POSSIBLY RELATED TO DEVICE AND POSSIBLY RELATED TO PROCEDURE. DEVICES WILL NOT BE RETURNED. NO FURTHER INFORMATION KNOWN.

  Patient problems: Post Operative Wound Infection

  MAUDE report 17808356 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K191561. One submission often covers many models, so check the product and lot details in each record.

• Z-1977-2021 · May 11, 2021 · Completed
  Humeral Augmented Tray (HAT) trials that are components of KIT-321HAT. Each tray contains 1 of each of the following catalog numbers for a total of 6 trials/tray: (1) HAT STD