Equinoxe 320-20-38Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885862086570), received between Apr 3, 2019 and Apr 28, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (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 18, 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.

• InjuryApr 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THE MALE PATIENT PRESENTED TO SURGEON'S OFFICE IN THE SPRING OF 2023 WITH COMPLAINTS OF SUDDEN AND THEN ONGOING PAIN AND DISSATISFACTION WITH HIS LEFT REVERSE TSA. UPON IMAGING THE IMPLANTS LOOKED MAL-POSITIONED AND THE GLENOID LOOKED LIKE IT HAS BONE GROWTH FROM POLY WEAR. THE SURGEON THOUGHT POLY WEAR AND OSTEOLYSIS CAUSED ONGOING ISSUES AND POTENTIAL LOOSENING OF THE IMPLANTS. THE PATIENT WAS SCHEDULED FOR REVISION LEFT REVERSE TSA. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Metal Related Pathology; Osteolysis; Pain

  MAUDE report 21919884 ↗
• InjuryJan 13, 2021Break; Break

  AS REPORTED, THE INDICATION WAS A REVERSE SHOULDER FOR A PRIMARY SURGERY ON THIS (B)(6) Y/O PATIENT. THE SURGEON NOTICED THAT THE BONE WAS VERY DENSE WHEN HE MORCELLED THE CANCELLOUS BONE TO PREPARE THE GRAFT FOR THE CAGE OF THE BASEPLATE. WHEN THE SURGEON DRILLED FOR THE INFERIOR SCREW (THE FIRST ONE), HE ASKED FOR A GREEN 4.5 COMPRESSION SCREW. THE SURGEON TOLD IT WAS VERY HARD TO SCREW, AND THEN CHANGED THE USUAL AND APPROPRIATE EQUINOXE HANDLE FOR THE T-HANDLE. THE SCREW BROKE AT THE JUNCTION OF THE THREADED PART WITH THE NON-THREADED PART, JUST BELOW THE HEAD. THE PART CONTAINING THE HEAD WAS THROWN AWAY. THE SCREW WAS ALMOST FULLY ENGAGED IN A WAY THAT THE SURGEON THINKS THAT THE PART LEFT IN THE PATIENT CANNOT BE SEEN ON X-RAYS AS A BROKEN PART OF A SCREW. THE CAP WAS SCREWED AS USUAL, WITH NO DIFFICULTIES. THE CHOICE WAS NOT CONFIRMED BY THE USE OF THE DEPTH GAUGE. THE AGENT REPORTED THAT THE COLOR CODE OF THE DRILL WAS NOT DAMAGED AND STILL READABLE. THE SURGEON FELT THAT THE STABILITY OF THE BASEPLATE WITH 3 SCREWS LEFT IN PLACE ON SUCH A HARD BONE WON¿T FAIL. NO ADDITIONAL SURGICAL TIME TO REPORT DUE TO THIS INCIDENT. THE DEVICES WERE DISPOSED OF BY THE FACILITY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11162707 ↗
• InjuryApr 3, 2019Loose or Intermittent Connection

  REVISION DUE TO INFECTION. IT WAS INFECTED AND LOOSE.

  Patient problems: Unspecified Infection

  MAUDE report 8477650 ↗

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-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-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-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-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-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-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.