Equinoxe 320-10-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10885862086440), received between Feb 16, 2022 and Dec 22, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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.

• InjuryDec 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A MALE PATIENT, WHO HAD A RIGHT RTSA, UNDERWENT A REVISION PROCEDURE. THE LOCKING SCREW CAME OUT OF THE SPHERE. THE SPHERE, TRAY, POLY, AND LOCKING SCREW WERE REVISED WITH NEW IMPLANTS. THERE WERE NO DEVICE BREAKAGES DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. AN X-RAY WAS PROVIDED. THE EXPLANTED DEVICE IS NOT AVAILABLE FOR RETURN DUE TO HOSPITAL POLICIES. NO FURTHER INFORMATION THIS IS 1 OF 3 REPORTS FOR THIS EVENT. THIS IS 1 OF 2 EVENTS FOR THIS PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 23866621 ↗
• InjuryAug 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AFTER 10 MONTHS, A PATIENT HAD A REVISION DUE TO LINER ASSOCIATION. THERE WAS NO ADDITIONAL INJURY OT THE PATIENT. PATIENT REVISED TO EXACTECH DEVICES: LINER AND ADAPTER TRAY WERE EXCHANGED .PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. UNABLE TO OBTAIN IMAGES OR X-RAYS. PRODUCT NOT RETURNING: DISPOSED.

  Patient problems: Insufficient Information

  MAUDE report 19909529 ↗
• InjurySep 28, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED A 69 YO 143 LB MALE PATIENT WAS REVISED DUE TO RIGHT SHOULDER DISLOCATION. THE LINER WAS WELL FIXED TO THE TRAY. PATIENT WAS NOT REVISED TO EXACTECH IMPLANTS. IMPLANT AND REVISION DATES ARE UNKNOWN. DEVICES ARE NOT RETURNING; UNAVAILABLE. NO OTHER INFORMATION IS KNOWN BY THE REPORTER. NO ADDITIONAL INFORMATION.

  Patient problems: Joint Dislocation

  MAUDE report 15500736 ↗
• InjuryFeb 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THIS (B)(6) MALE PATIENT'S LEFT SHOULDER WAS REVISED DUE TO INSTABILITY. SURGEON REMOVED IN-SITU HUMERAL ADAPTER TRAY, LINER AND GLENOID SPHERE, AND REPLACED WITH LARGER DIAMETER SPHERE AND NEW HUMERAL TRAY AND POLY LINER. NO NEGATIVE OUTCOMES AFTER SURGERY.

  Patient problems: Failure of Implant

  MAUDE report 13541734 ↗