Equinoxe 301-08-21Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862580405), received between Jan 24, 2024 and Jan 24, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

10 other recalls cover devices cleared under the same FDA submission (K042021, K061454); 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.

• InjuryJan 24, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A MALE PATIENT, INITIAL RIGHT SHOULDER IMPLANTED ON (B)(6) 2023, UNDERWENT A REVISION PROCEDURE ON (B)(6), 2023. DURING THE COURSE OF THE INITIAL SURGERY, THE HUMERAL HEAD PROTECTOR DISASSOCIATED FROM THE TRIAL PRESERVE STEM. THE EVENT WAS NOT NOTICED. THE DISASSOCIATED HUMERAL HEAD PROTECTOR MOVED POSTERIOR TO THE GLENOID AND WAS THEREFORE NOT VISIBLE FROM THE INCISION. THE SURGERY WAS COMPLETED SUCCESSFULLY, HOWEVER THE DEVICE COMPONENT REMAINED IN THE SHOULDER WHICH THE SURGEON BECAME AWARE OF DURING A REVIEW OF POST OPERATIVE X-RAYS. THERE WAS AN INSTRUMENT COUNT COMPLETED PRIOR TO WOUND CLOSURE, BUT THIS INSTRUMENT WAS NOT INCLUDED IN THE COUNT. THE REVISION SURGERY WAS COMPLETED TO REMOVE THE INSTRUMENT. THE GLENOSPHERE, TRAY, AND LINER WERE EXCHANGED, AND THE HUMERAL HEAD PROTECTOR WAS SUCCESSFULLY REMOVED. REMOVING THE DEVICE CAUSED A GREATER THAN 45-MINUTE SURGICAL DELAY/PROLONGATION DURING THE PROCEDURE. THERE WAS NO ADVERSE EVENT TO THE PATIENT AS A RESULT. NO PATIENT INFORMATION, X-RAYS OR IMAGES WERE PROVIDED. THE DEVICE IS AVAILABLE FOR RETURN. NO FURTHER INFORMATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 18576347 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K042021, K061454. 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-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-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-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-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-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-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-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