Equinoxe 321-05-21Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862534200), received between Jun 3, 2021 and Jun 3, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

1 other recall cover devices cleared under the same FDA submission (K162726); 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. How this data works · Data updated Oct 13, 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.

• MalfunctionJun 3, 2021Break; Break

  AS REPORTED, ON MAY 3RD A STAFF MEMBER FROM STERILE PROCESSING FOUND A WIRE THAT WAS PROTRUDING OUT OF THE INNER RIM OF THE PRESERVE ADAPTER TRAY TRIAL. THE STERILIZATION DEPARTMENT WANTED TO KNOW IF THIS WAS HAZARDOUS AND IF IT HAD TO BE REMOVED/INSERTED BACK IN FOR CLEANING. STAFF ENDED UP REMOVING THE WIRE FOR CLEANING AND FOUND DEBRIS UNDER THE WIRE. ON MAY 7TH, IT WAS CONFIRMED THAT THE WIRE IS IN FACT A SPRING TO HELP WITH KEEPING THE INSERTS IN PLACE DURING TRIAL REDUCTION. HOWEVER, THE CUSTOMER IS SENDING THE INSTRUMENT BACK TO EXACTECH FOR INVESTIGATION TO ENSURE THERE IS NOTHING DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11928829 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K162726. One submission often covers many models, so check the product and lot details in each record.

• Z-0958-2019 · Dec 5, 2018 · Terminated
  Equinoxe Preserve Humeral Stem, 8mm Product Usage: The Equinoxe Preserve Stems are indicated for use in skeletally mature individuals with degenerative diseases of the glenohumera