Equinoxe 310-03-53Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862083999), received between Jul 1, 2020 and Mar 30, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 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.

• InjuryMar 30, 2024Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated

  AS REPORTED BY THE EQUINOXE SHOULDER STUDY, THE 64-YEAR-OLD MALE PATIENT HAD A LEFT TSA ON (B)(6) 2022. THE PATIENT PRESENTED WITH A INSTABILITY / SUBLUXATION ON (B)(6) 2023. SHOULDER CONTINUED TO SUBLUXATE POST-OPERATIVELY, ESPECIALLY AT NIGHT. PATIENT ALSO DEVELOPED A FISTULA AND A DRAINING SINUS. THIS EVENT IS RELATED TO (B)(4). THE OUTCOME OF THIS EVENT IS CONSIDERED RESOLVED ON (B)(6) 2023 BY THE ACTION OF REVISION. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS POSSIBLY 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: Fistula; Joint Dislocation; Joint Laxity; Subluxation

  MAUDE report 19009221 ↗
• InjuryJul 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, AFTER APPROXIMATELY 2.5 MONTHS POSTOP FROM THE ANTIBIOTIC SPACER PLACEMENT, CONCERN FOR INFECTION WAS GONE, THE PATIENT AND SURGEON DECIDED TO REVISE TO A REVERSE TSA FOR BETTER FUNCTION DUE TO ROTATOR CUFF DEFICIENCY. A REVERSE WAS IMPLANTED RETAINED THE ORIGINAL STEM. THE PATIENT WAS BROUGHT THROUGH A SATISFACTORY AND STABLE RANGE OF MOTION AND THE PROCEDURE WAS COMPLETED. THE PATIENT LEFT THE OPERATING ROOM STABLE AND THE SURGEON EXPECTS A GOOD OUTCOME. DEVICES WILL NOT RETURN DUE TO HOSPITAL POLICY.

  Patient problems: Bacterial Infection

  MAUDE report 10220730 ↗

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-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-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-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-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