Equinoxe 314-02-03 (UDI 10885862657770)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862657770), received between Oct 15, 2025 and Oct 15, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (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. How this data works · Data updated Oct 13, 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.

• InjuryOct 15, 2025Fracture; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT HAD A PREVIOUS STEMMED ANATOMIC SHOULDER REPLACEMENT, THE POLY GLENOID HAD BECOME LOOSE, AND HAD COME AWAY FROM THE GLENOID. AFTER REMOVING THE IMPLANT, THE SURGEON NOTICED THAT THE INFERIOR POSTERIOR PEG HAD BROKEN AND WAS NOT ATTACHED TO THE IMPLANT. IT WAS STILL CEMENTED INTO THE GLENOID, SO THE SURGEON USED A BURR TO REMOVE THE REMAINING PEG. THE SURGEON REMOVED ALL IMPLANTS AND INSERTED A CEMENT SPACER PREPARING FOR THE 2ND STAGE REVISION WHICH THE PATIENT WILL COME BACK FOR. DUE TO THE STEM BEING EXTREMELY SECURE, THE PATIENTS GT (GREATER TUBEROSITY) BROKE WHILST REMOVING THE STEM. THE SURGEON EXPLAINED TO THE PATIENT THEY WILL PROBABLY REQUIRE A HRP AS PART OF THE 2ND STAGE REVISION. THERE WERE DEVICE BREAKAGES AND THERE WERE FRAGMENTS, PARTS, PIECED IN THE WOUND SITE WHICH WERE REMOVED BY THE SURGEON AND A WASH OUT OCCURRED. THERE WERE NO SURGICAL DELAYS DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS WERE AVAILABLE. THE EXPLANTED DEVICE IS AVAILABLE FOR RETURN. DEVICE IMAGES WERE PROVIDED. PROSTHESIS WEAR WAS OBSERVED IN THE IMAGES. NO FURTHER INFORMATION.

  Patient problems: Bone Fracture(s); Septic loosening; Unspecified Infection

  MAUDE report 23286871 ↗

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-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-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-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-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-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