Equinoxe 315-25-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862085344), received between Feb 11, 2021 and Feb 11, 2021 — classified as 1 injury.

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

18 other recalls cover devices cleared under the same FDA submission (K042021, K093430, K113309); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 11, 2021Break; Break

  AS REPORTED, THE PILOT TIP REAMER CAUGHT THE RETRACTOR AND BROKE INTO MULTIPLE PIECES. THIS CAUSED NO ISSUE TO THE PATIENT OR PROCEDURE. ALL PIECES WERE REMOVED FROM THE PATIENT. SURGERY RESUMED AFTER THE PIECES WERE REMOVED. DEVICE WAS BROKEN INTO MANY PIECES AND WILL NOT RETURN. THERE WAS NO ADVERSE OUTCOME TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11312983 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K042021, K093430, K113309. One submission often covers many models, so check the product and lot details in each record.

• 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-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-1413-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47
• Z-1412-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 3
• 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-1415-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Numbe
• 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-1414-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number
• 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-0884-2021 · Nov 9, 2020 · Open, Classified
  Equinoxe Humeral Stem, Primary, Press Fit, 11mm
• Z-0460-2021 · Oct 6, 2020 · Terminated
  Catalog 314-13-33, Equinoxe Cage Glenoid, Posterior Augment, Right, Medium
• Z-0459-2021 · Oct 6, 2020 · Terminated
  Catalog 314-13-23, Equinoxe Cage Glenoid, Posterior Augment, Left, Medium
• Z-0415-2018 · Aug 31, 2017 · Terminated
  Equinoxe Cage, Glenoid, Alpha, Medium Product Usage: The Equinoxe Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases or fractures of

…and 3 more.