Equinoxe 309-10-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10885862267719), received between Feb 8, 2022 and Aug 20, 2024 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 20, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A REVISION PROCEDURE OF A RIGHT-SIDE SHOULDER DUE TO A FRACTURE OF IMPLANTS, A PRONG ON THE 25 HRP MIDDLE SEGMENT BROKE OFF WHILE DISENGAGING FROM THE PROXIMAL BODY TRIAL. NO PARTS OR PIECED FELL INTO THE WOUND SITE. THERE WERE NO SURGICAL DELAYS DURING THE PROCEDURE. THE (B)(6) YO MALE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION DURING THE EVENT. X-RAYS WERE PROVIDED. THE FRACTURED TRIAL IS AVAILABLE FOR RETURN. AN IMAGE OF THE BROKEN TRIAL WAS PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Limb Fracture

  MAUDE report 20000732 ↗
• InjuryNov 2, 2023Break; Break

  IT WAS REPORTED THAT WHEN USING THE 25MM SEGMENT TRIAL 1 OF THE PLASTIC TABS BROKE OFF THE TRIAL. THE TRIAL WAS STILL ABLE TO BE USED AND THERE WAS NO DELAY TO THE SURGERY OR ANY PLASTIC PIECES LEFT IN THE PATIENT. NO PARTS OR PIECES LEFT IN THE PATIENT. NO SURGICAL DELAY/PROLONGATION. NO PATIENT INFORMATION REPORTED. DEVICE IS RETURNING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18059498 ↗
• MalfunctionSep 2, 2022Break; Break

  DURING SURGICAL USE, UPON REMOVAL OF THE TRIAL SEGMENT FROM THE STEM IN SITU, THE 4 "LEGS" OF THE TRIAL BROKE. THE PIECES WERE RETRIEVED AND ACCOUNTED FOR. NO SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15349299 ↗
• MalfunctionFeb 8, 2022Break; Break

  AS REPORTED, THE TRIAL BROKE DURING USE IN SURGERY. ONE OF THE FLANGES BROKE OFF DURING THE TRIAL PROCESS. THERE WAS NO SURGICAL DELAY OR PROLONGATION AND NO PARTS OR PIECES THAT FELL INTO THE PATIENT¿S WOUND. THE PRODUCT IS AVAILABLE FOR RETURN. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. AFTER NEW INFORMATION WAS RECEIVED FROM THE ENGINEERS DURING THEIR INVESTIGATION, THIS DEVICE HAS BEEN DETERMINED TO BE REPORTABLE DUE TO THE NATURE OF THE BREAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13479852 ↗