Equinoxe 300-30-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885862515803), received between May 29, 2019 and May 5, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 5, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT A PATIENT WHO HAD A RIGHT RTSA, UNDERWENT A REVISION PROCEDURE. THE HUMERAL TRAY WAS DISSOCIATED FROM THE PRESERVE STEM. THE TORQUE SCREW WAS EXPLANTED AND INTACT (DID NOT APPEAR BROKEN). THE REPORTED EVENT WAS RELATED TO A DEVICE BREAKAGE BUT NO PARTS OR PIECES WERE IN THE WOUND SITE. THE TORQUES SCREW WAS REVISED. THERE WERE NO SURGICAL DELAYS REPORTED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS WERE AVAILABLE. THE EXPLANTED DEVICE IS AVAILABLE FOR RETURN. NO FURTHER INFORMATION. THIS IS 1 OF 2 REPORTS FOR THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 25089176 ↗
• InjuryMay 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN INITIAL SHOULDER PROCEDURE, DURING THE IMPLANTATION OF THE HUMERAL STEM, WHEN IMPACTING A 12 MM PRESERVE STEM DOWN, THEY ENDED UP CAUSING A SMALL CRACK IN THE HUMOROUS. THE CRACK WAS REPAIRED, AND THEY USED A CABLE AROUND THE HUMOROUS. THE IMPLANT WAS FOUND TO BE FULLY STABLE. THIS CAUSED A 10-15 MINUTE DELAY, BUT THE REP DID NOT BELIEVE THERE WE ANY NEGATIVE IMPACTS TO THE PATIENT. DEVICE RETURN IS NOT APPLICABLE. NO FURTHER INFORMATION.

  Patient problems: Bone Fracture(s); Periprosthetic fracture

  MAUDE report 16848367 ↗
• InjuryMay 29, 2019Appropriate Device Problem Term/Code Not Available

  INDEX SURGERY: 2018. PATIENT'S RIGHT SHOULDER DID NOT HEAL PROPERLY, AND A LATER ARTHROSCOPIC SURGERY COULD NOT REPAIR IT AND IT BECAME INFECTED. PATIENT NEEDS SURGERY TO REMOVE THE METAL AND INSTALL AN ANTIBIOTIC SPACER.

  Patient problems: Impaired Healing; Unspecified Infection

  MAUDE report 8649586 ↗

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 glenohum