Equinoxe 320-10-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10885862086433), received between Apr 15, 2019 and Oct 27, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryOct 27, 2025Detachment of Device or Device Component; Naturally Worn; Detachment of Device or Device Component; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT REVERSE TOTAL SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT EXPERIENCED PAIN APPROXIMATELY 5 YEARS AND 6 MONTHS AFTER INITIAL IMPLANTATION. RADIOGRAPHS TAKEN SHOWED THAT THE HUMERAL LINER AND HUMERAL TRAY HAD DISASSOCIATED. AS A RESULT, THE PATIENT UNDERWENT A LEFT SHOULDER REVISION APPROXIMATELY 6 YEARS AND 10 MONTHS AFTER INITIAL IMPLANTATION. PROVIDED IMAGES OF THE EXPLANTED DEVICES SHOW SIGNS OF WEAR AND METAL-RELATED PATHOLOGY. NO FURTHER PATIENT IMPACT REPORTED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Discomfort; Metal Related Pathology; Pain

  MAUDE report 23390816 ↗
• InjuryMay 7, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED BY THE EQUINOXE SHOULDER STUDY, THE PATIENT HAD A LEFT TSA ON AND PRESENTED WITH DISASSOCIATION OF POLYETHYLENE. PATIENT DISLOCATED HIS REVERSE AND DISASSOCIATED HIS POLY COMPONENT GETTING OFF THE FLOOR. THE OUTCOME OF THIS EVENT IS CONSIDERED RESOLVED. THE ACTION TAKEN WAS REVISION WITH THE REMOVAL OF THE TORQUE SCREW, HUMERAL TRAY, HUMERAL LINER, GLENOSPHERE, GLENOSPHERE LOCKING SCREW. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS NOT RELATED TO THE DEVICE AND/OR TO THE PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES AND NO DEVICE RETURN IS ANTICIPATED.

  Patient problems: Joint Dislocation

  MAUDE report 21976415 ↗
• InjuryNov 27, 2024Detachment of Device or Device Component; Naturally Worn; Detachment of Device or Device Component; Naturally Worn

  AS REPORTED, APPROXIMATELY 5 YEARS AND 9 MONTHS POST INITIAL LEFT TOTAL SHOULDER ARTHROPLASTY (TSA) FOR SECONDARY ARTHRITIS AND A MASSIVE ROTATOR CUFF TEAR AND APPROXIMATELY 2 YEARS AND 5 MONTHS POST REVISION FOR PROSTHETIC DISLOCATION CAUSED BY DISASSEMBLY OF THE POLYETHYLENE INSERT, A SECOND REVISION WAS PERFORMED DUE TO PAIN REPORTED BY THE PATIENT AT WHICH TIME THE GLENOSPHERE, HUMERAL LINER, AND HUMERAL ADAPTER TRAY WERE REPLACED. THE HUMERAL LINER WAS CHANGED TO A CONSTRAINED HUMERAL LINER. DESPITE THE REVISIONS, THE INSERT CONTINUED TO DISASSEMBLE, AND THE INNER JOINT EXHIBITED AN UNUSUAL BROWNISH DISCOLORATION INDICATING METALLOSIS. EVENT AND PATIENT OUTCOME WERE NOT PROVIDED.

  Patient problems: Joint Dislocation; Metal Related Pathology; Pain

  MAUDE report 20792535 ↗
• InjuryAug 22, 2024Unstable; Detachment of Device or Device Component; Unstable; Detachment of Device or Device Component

  APPROXIMATELY 4 YEAR(S), 3 MONTH(S) AND 19 DAY(S) POST-OPERATIVE OF A REVISED LEFT TSA, THE PATIENT PRESENTED WITH DISASSOCIATION OF POLYETHYLENE. PATIENT DESCRIBES INSTABILITY EVENT 2 WEEKS AGO. THE PATIENT UNDERWENT STANDARD REVERSE REVISION SURGERY AND THE OUTCOME OF THIS EVENT IS CONSIDERED RESOLVED. THE CLINICAL REPORT INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO THE DEVICE(S) AND DEFINITELY NOT RELATED TO THE PROCEDURE.

  Patient problems: Insufficient Information; Joint Laxity

  MAUDE report 20031927 ↗
• InjuryApr 15, 2019Device Dislodged or Dislocated

  REVISION DUE TO DISLOCATION.

  Patient problems: No Code Available

  MAUDE report 8513705 ↗

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-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-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-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-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-3019-2020 · Aug 24, 2020 · Terminated
  Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 18 mm.
• Z-3020-2020 · Aug 24, 2020 · Terminated
  Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 22 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.