Equinoxe 304-22-07Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885862083388), received between Sep 16, 2020 and Jun 9, 2026 — classified as 3 injuries.

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

• InjuryJun 9, 2026Migration

  IT WAS REPORTED VIA A CLINICAL STUDY, THAT A PATIENT WHO HAD A RIGHT RTSA, UNDERWENT A FRACTURE REVERSE REVISION PROCEDURE. THE HUMERAL STEM SUBSIDED DESPITE BEING CEMENTED CAUSING A PERI PROSTHETIC HUMERAL FRACTURE. THE FRACTURE HUMERAL STEM, HUMERAL TRAY, HUMERAL LINER WERE REMOVED. THE STUDY INDICATED IT WAS POSSIBLY RELATED TO THE DEVICES AND THE PROCEDURE. THE OUTCOME STATES CONTINUING. NO FURTHER INFORMATION.

  Patient problems: Bone Fracture(s)

  MAUDE report 25451685 ↗
• InjuryJul 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, DURING THE INITIAL RTSA ON THIS (B)(6) FEMALE, AS THE SURGEON WERE IMPACTING THE STEM, THEY NOTICED THE LESSER TUBEROSITY FRAGMENT HAD FRACTURED. THEY WERE THEN ABLE TO IMPACT THE STEM INTO POSITION. THE SURGEON NOTED THERE IS NO EXTENSION OF THE FRACTURE DOWN THE HUMERAL CANAL. A FIBER-WIRE CERCLAGE TAPE WAS PLACED JUST DISTAL TO WHERE THE FRACTURE LINE WAS TO PREVENT ANY FURTHER PROPAGATION DURING FINAL IMPLANTATION. THIS PATIENT HAS KNOWN OSTEOGENESIS IMPERFECTA. THE CASE REPORT FORM INDICATES THIS EVENT IS UNLIKELY RELATED TO DEVICES AND POSSIBLY RELATED TO THE PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES.

  Patient problems: Bone Fracture(s)

  MAUDE report 12141936 ↗
• InjurySep 16, 2020Inaccurate Information; Inaccurate Information

  AS REPORTED, DURING AN IMPLANT PROCEDURE ON THIS (B)(6) Y/O FEMALE PATIENT, THE SURGEON REAMED AND ASKED FOR A 6.5MM R IMPLANT. IMPLANT WAS CHOSEN AS R 6.5 PLATFORM FX STEM (LABEL ON BOX-304-22-07, SN (B)(4)) AND OPENED. THE SURGEON TRIED TO IMPLANT BEFORE NOTICING IT WAS A LEFT (IMPLANT LABELED- 304-22-07, SN (B)(4)). NO BACK UP IMPLANT WAS AVAILABLE WITHIN 100 MILES. COULD NOT CEMENT SMALLER. SURGEON GENTLY POWER REAMED UP 0.5MM AT A TIME WITH DIFFERENT REAMERS TO 8.5 AND WAS ABLE TO USE AN 8.5. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE TO BE RETURNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10540435 ↗

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-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