Equinoxe 304-21-13Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862083371), received between Dec 26, 2025 and Dec 26, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 26, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A MALE PATIENT, WHO HAD AN INITIAL LEFT SHOULDER IMPLANTED IN (B)(6) 2023, UNDERWENT A REVISION PROCEDURE, DATE UNKNOWN. THE PATIENT REPORTED LOOSENING OF THE IMPLANT OR INSTABILITY IN THEIR AFFECTED SHOULDER. THE PLAN WAS TO EXTRACT THE FX. STEM AND IMPLANT A LONG STEM, POSSIBLY USE HAT OR HRP. WHILE DOCTOR WAS EXPLANTING, THE HUMERAL SIDE, HE NOTICED LOOSENING OF THE GLENOID BASEPLATE AND EXTRACTED EVERYTHING. DR. DETERMINED THE JOINT WAS INFECTED AND USED A SPACER. A COMPETITOR¿S DEVICE WAS USED. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS WERE PROVIDED. IT IS UNKNOWN IF THE EXPLANTED DEVICES WILL BE MADE AVAILABLE AT THIS TIME AS IT IS CONTINGENT ON THE PATIENT¿S APPROVAL.

  Patient problems: Joint Laxity; Medical device site infection; Septic loosening

  MAUDE report 23897047 ↗

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-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-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-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
• 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