Equinoxe 304-21-07Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862083340), received between Oct 8, 2024 and Nov 27, 2024 — classified as 2 injuries.

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

4 other recalls cover devices cleared under the same FDA submission (K092900, K101909); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 27, 2024Fracture; Fracture

  IT WAS REPORTED THAT THIS PATIENT HAD A REVISION ON THEIR LEFT REVERSE TOTAL SHOULDER ARTHROPLASTY. THIS STEM FRACTURED WHICH RESULTED IN PROXIMAL HUMERUS FRACTURE WHICH REQUIRED A HUMERAL RECONSTRUCTION PROSTHESIS (HRP) TO BE CARRIED OUT. THE STEM, TRAY, LINER AND GLENOSPHERE WERE ALL REVISED AND A HRP WAS PUT IN. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PRODUCTS NOT RETURNING: HOSPITAL HAVE NOT DECONTAMINATED.

  Patient problems: Limb Fracture

  MAUDE report 20796831 ↗
• InjuryOct 8, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 8 YEARS AND 3 MONTHS POST THE INITIAL LEFT TSA, THE PROXIMAL HUMERUS HAS RESORBED AWAY AND OVER TIME THE STEM HAS COME LOOSE FROM MOVING LIKE A WINDSHIELD WIPER OVER TIME. THE SURGEON WAS ABLE TO REMOVE THE HUMERAL CONSTRUCT WITH HIS HAND. THE 38MM GLENOSPHERE WAS EXPLANTED AS WELL AND RE-IMPLANTED A 42MM GLENOSPHERE. AN 8 X 175MM LONG REVISION STEM WAS RE-IMPLANTED IN THE HUMERUS ALONG WITH A +0MM TRAY AND +2.5MM LINER. 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: Insufficient Information; Pain

  MAUDE report 20404068 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K092900, K101909. One submission often covers many models, so check the product and lot details in each record.

• Z-0307-2021 · Sep 25, 2020 · Terminated
  Equinoxe Platform Fracture Stem, 6.5mm, Left - Product Usage: The Equinoxe Platform Fracture Stem is indicated for cemented use only.
• Z-0308-2021 · Sep 25, 2020 · Terminated
  Equinoxe Platform Fracture Stem, 6.5mm, Right - Product Usage: The Equinoxe Platform Fracture Stem is indicated for cemented use only.
• Z-0873-2020 · Dec 3, 2019 · Terminated
  Exactech equinoxe PLATFORM FRACTURE, HUMERAL STEM, CEMENTED, Right, 10.5mm, REF 304-22-11 - Product Usage: The Equinoxe Shoulder System is indicated for use and in skeletally matur
• Z-0872-2020 · Dec 3, 2019 · Terminated
  Exactech equinoxe PLATFORM FRACTURE, HUMERAL STEM, CEMENTED, Right, 6.5mm, REF 304-22-07 - Product Usage: The Equinoxe Shoulder System is indicated for use and in skeletally mature