Equinoxe 300-30-09Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885862515773), received between Oct 28, 2024 and Jan 6, 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.

• InjuryJan 6, 2026Detachment of Device or Device Component; Lack of Effect

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT REVERSE TOTAL SHOULDER REVISION. SUBSEQUENTLY, THE PATIENT'S TORQUE DEFINING SCREW SEPARATED FROM THE HUMERAL STEM RESULTING IN DISASSOCIATION OF THE HUMERAL TRAY. AS A RESULT, THE PATIENT UNDERWENT AN ADDITIONAL SHOULDER REVISION SURGERY APPROXIMATELY 6 MONTHS AFTER THEIR FIRST REVISION SURGERY AND 6 YEARS AFTER THEIR INITIAL IMPLANTATION. NO FURTHER PATIENT IMPACT REPORTED. NO FURTHER INFORMATION AVAILABLE. THIS IS REPORT 2 OF 2 FOR THIS EVENT.

  Patient problems: Insufficient Information; Loss of Range of Motion; Pain

  MAUDE report 23981470 ↗
• InjuryDec 8, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TSA (TOTAL SHOULDER ARTHROPLASTY) ON THE RIGHT SIDE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO THE INITIAL GLENOSPHERE BEING TOO BIG. THE SURGEON INITIALLY THOUGHT THE STEM WAS LOOSE. AS A RESULT, THE SURGEON REMOVED THE 42MM GLENOSPHERE AND REPLACED WITH 38MM GLENOSPHERE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23746255 ↗
• InjuryOct 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INTRA-OPERATIVELY OF A RIGHT RTSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED A HUMERAL FRACTURE. IT WAS FURTHER REPORTED THAT A SMALL MEDIAL CALCAR CRACK OCCURRED DURING TRIALING. THE ACTION TAKEN DURING THE PROCEDURE WAS CEMENTED STEM AND THE OUTCOME OF THIS EVENT REMAINS CONTINUING. THE CLINICAL REPORT INDICATES THAT THIS EVENT IS UNLIKELY RELATED TO THE DEVICE(S) AND POSSIBLY RELATED TO THE PROCEDURE.

  Patient problems: Bone Fracture(s); Limb Fracture

  MAUDE report 20550404 ↗

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