Equinoxe 310-02-47Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862083944), received between Feb 8, 2023 and Mar 10, 2025 — classified as 2 injuries.

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

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 16, 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.

• InjuryMar 10, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  APPROXIMATELY 9 MONTH(S) AND 17DAY(S) POST-OPERATIVE OF A REVISED LEFT TSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED A SUBSCAPULARIS TEAR. SIGNIFICANT WEAKNESS, PAIN WITH INTERNAL ROTATION; INSTABILITY WERE REPORTED FOR THE PATIENT. THE PATIENT UNDERWENT A STANDARD HEMI WITH PRESERVE STEM REVISION WITH THE REPORTED REMOVAL OF THE HUMERAL HEAD. IT WAS PREVIOUSLY REPORTED THAT THE PATIENT UNDERWENT A REVISION DUE TO LOOSENING AND DISASSOCIATION OF THE POLYETHYLENE CAPTURED ON REPORT 1038671-2024-03028; AND A REVISION PRIOR TO THAT FOR UNKNOWN REASON WAS ALSO CAPTURED ON REPORT 1038671-2025-01514. THIS WAS REPORTED THROUGH CLINICAL TRIAL STUDY DATA COLLECTION ACTIVITIES, NO DEVICE RETURN IS ANTICIPATED, AND NO OTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Joint Laxity; Muscle Weakness/Atrophy; Muscle/Tendon Damage; Pain

  MAUDE report 21561666 ↗
• InjuryFeb 8, 2023Patient Device Interaction Problem; Migration; Patient Device Interaction Problem; Migration

  AS REPORTED, POST-OP X-RAYS REFLECTED IDEAL IMPLANT POSITIONING ON SURGERY DATE (B)(6) 2022. ANATOMIC SHOULDER REPLACEMENT REDUCED PAIN BUT UPON SOME SUBSCAP AND SUPRASPINATUS TEARS, HUMERUS WAS HIGH RIDING. THE SURGEON DECIDED TO UPSIZE THE HUMERAL STEM, CHANGE THE REPLICATOR SIZE AND USE THE SHORTER 47 HUMERAL HEAD, RATHER THAN CONVERTING TO REVERSE. PATIENT WAS ADAMANT ABOUT AN ANATOMIC REPLACEMENT. THIS IS WHAT PARTIALLY DETERMINED THE REVISION TO REDO THE ATSA, RATHER THAN CONVERTING TO RTSA. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Arthropathy; Failure of Implant

  MAUDE report 16321759 ↗

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-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 Component: N
• 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 Compo
• 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 Component: N
• 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-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-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-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-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