Equinoxe 320-20-18Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862086525), received between May 29, 2026 and May 29, 2026 — classified as 1 injury.

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

13 other recalls cover devices cleared under the same FDA submission (K063569); 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.

• InjuryMay 29, 2026Naturally Worn

  AS REPORTED, APPROXIMATELY 5 YEARS AND 2 MONTHS POST THE INITIAL RIGHT REVERSE TOTAL SHOULDER ARTHROPLASTY, THE PATIENT PRESENTED TO THE SURGEON'S OFFICE WITH COMPLAINTS OF PAIN AND DECREASED RANGE OF MOVEMENT. UPON EXAMINATION AND IMAGING REVIEW FROM PREVIOUS POST-OP, AND THE RECENT OFFICE VISIT X-RAYS, AND ACCORDING TO THE IMPLANT RECORD WITH A STANDARD BASEPLATE BEING USED, IT APPEARED THE GLENOSPHERE WAS NOT COMPLETELY ENGAGED AND DOWN ON THE BASEPLATE. HOWEVER, THE LOCKING SCREW WAS STILL ENGAGED AND GAVE THE SURGEON A FALSE FEEDBACK IN THE INITIAL SURGERY THAT THE IMPLANT WAS DOWN AND SECURE. THE IMPLANT WAS NOT DOWN COMPLETELY AND SECURE, AND OVER TIME THE GLENOSPHERE LOCKING SCREW DISENGAGED FROM THE MECHANISM AND THE GLENOSPHERE IMPLANT LEVERAGED OFF OF THE GLENOID BASEPLATE. THERE WAS/IS EVIDENCE OF HUMERAL POLY LINER WEAR AND BONE RESORPTION/OSTEOLYSIS AROUND THE IMPLANTS. THE PATIENT WAS REVISED, AND DURING THE REVISION, THE PATIENT'S SHOULDER JOINT AND SURROUNDING TISSUE SHOWED METALLOSIS. THE JOINT AND TISSUES WERE DEBRIDED. THE BROKEN AND DISENGAGED IMPLANTS WERE REMOVED. THE HUMERAL STEM WAS TESTED FOR STABILITY. THE GLENOID BASEPLATE SHOWED TO BE STABLE, SO THE SUR

  Patient problems: Loss of Range of Motion; Metal Related Pathology; Osteolysis; Pain

  MAUDE report 25336598 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K063569. One submission often covers many models, so check the product and lot details in each record.

• Z-2561-2025 · Aug 15, 2025 · Open, Classified
  Exactech Equinoxe, Reverse Shoulder Humeral Liners, REF: 320-38-00,145-DEG PE 38MM HUM LINER +0/ 320-38-03,145-DEG PE 38MM HUM LINER +2.5/ 320-42-00,145-DEG PE 42MM HUM LINER +0/
• Z-1419-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
• Z-1423-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
• Z-1422-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty
• Z-1425-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe REVERSE SHOULDER,46mmConstrained Humeral Liner, a) +0mm, Item number 320-46-10, b) +2.5mm, Item Number 320-46-13; Shoulder Arthroplasty
• Z-1424-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty
• Z-1418-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
• Z-0579-2024 · Nov 21, 2023 · Open, Classified
  Exactech Equinoxe Reverse Shoulder System, Catalog Numbers: a) 320-36-00, b) 320-36-03, c) 320-36-04, d) 320-36-10, e) 320-36-13, f) 320-38-00, g) 320-38-13, h) 320-40-00,
• Z-3020-2020 · Aug 24, 2020 · Terminated
  Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 22 mm.
• Z-3019-2020 · Aug 24, 2020 · Terminated
  Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 18 mm.
• Z-0012-2019 · Aug 21, 2018 · Open, Classified
  Equinoxe Reverse Drill Bit Kit, Catalog Number 321-20-00 Product Usage: Shoulder surgery
• Z-0900-2017 · Oct 25, 2016 · Terminated
  Equinoxe Reverse Shoulder Fixed Angle Torque Defining Screw Kit
• Z-2117-2012 · Jun 15, 2012 · Terminated
  Equinoxe Reverse Compression Screw Intended for Primary and Reverse Total Shoulder Arthroplasty.