Equinoxe 300-20-02 (UDI 10885862079473)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862079473), received between Apr 8, 2022 and Apr 8, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Off-Label Use” (2 reports).

10 other recalls cover devices cleared under the same FDA submission (K042021); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 8, 2022Off-Label Use; Off-Label Use

  IT WAS REPORTED THAT THIS PATIENT WAS REVISED DUE TO THE SURGEON IMPLANTING AN ANATOMIC SCREW IN A REVERSE TRAY. ANATOMIC TORQUE SCREWS WERE THEN USED WITH REVERSE HUMERAL TRAYS (ONE +10 AND ONE +15).

  Patient problems: Failure of Implant

  MAUDE report 14051010 ↗
• InjuryApr 8, 2022Off-Label Use; Off-Label Use

  IT WAS REPORTED THAT THIS PATIENT WAS REVISED DUE TO THE SURGEON IMPLANTING AN ANATOMIC SCREW IN A REVERSE TRAY. ANATOMIC TORQUE SCREWS WERE THEN USED WITH REVERSE HUMERAL TRAYS (ONE +10 AND ONE +15).

  Patient problems: Failure of Implant

  MAUDE report 14050983 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K042021. One submission often covers many models, so check the product and lot details in each record.

• Z-0537-2026 · Sep 5, 2025 · Open, Classified
  Brand Name: Equinoxe Ergo Product Name: Ergo Augments Pilot Tip Converter Model/Catalog Number: 301-11-11 Software Version: N/A Product Description: Pilot Tip Converter Piece
• Z-0536-2026 · Sep 5, 2025 · Open, Classified
  Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 46mm Model/Catalog Number: 321-59-46 Software Version: N/A Product Description: rTSA Reamer, 46mm Compone
• Z-0535-2026 · Sep 5, 2025 · Open, Classified
  Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 42mm Model/Catalog Number: 321-59-42 Software Version: N/A Product Description: rTSA Reamer, 42mm Compone
• Z-1405-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02
• Z-1403-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Nu
• Z-1404-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Nu
• Z-1402-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item
• Z-0884-2021 · Nov 9, 2020 · Open, Classified
  Equinoxe Humeral Stem, Primary, Press Fit, 11mm
• Z-1459-2015 · Feb 13, 2015 · Terminated
  Equinoxe 44mm Short Humeral Head Catalog Number 310-01-44. Orthopedic shoulder implant component.
• Z-2115-2012 · Jun 15, 2012 · Terminated
  Equinoxe Anatomic Replicator Plate Intended for Primary and Reverse Total Shoulder Arthroplasty