Equinoxe 306-01-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885862083784), received between Apr 3, 2019 and Apr 15, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 15, 2026Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA CLINICAL THAT THIS PATIENT UNDERWENT A SHOULDER REPLACEMENT. SUBSEQUENTLY, THE PATIENT EXPERIENCED SHOULDER PAIN ATTRIBUTED TO HUMERAL COMPONENT LOOSENING AND NONUNION. A REVISION PROCEDURE WAS PERFORMED, DURING WHICH THE HUMERAL STEM, HUMERAL TRAY, AND HUMERAL LINER WERE REVISED. THE OUTCOME IS CONSIDERED RESOLVED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Aseptic loosening; Nonunion/Delayed-union Bone Fracture; Pain

  MAUDE report 24889107 ↗
• InjuryOct 11, 2019Loose or Intermittent Connection; Component Missing; Positioning Problem; Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, THIS FEMALE PATIENT HAD A TOTAL SHOULDER ARTHROPLASTY ON HER RIGHT SHOULDER. WE ARE UNSURE OF WHEN THIS WAS PERFORMED AND BY WHOM. SHE HAD A SUBSEQUENT REVISION SURGERY WHICH TOOK PLACE ON (B)(6) 2014 AND WAS PERFORMED. IT SEEMS THAT THAT THE HUMERAL COMPONENTS WERE REVISED IN PLACE AND USED A HUMERAL LONG STEM (8X175) FOR THIS PATIENT. THE CEMENTED LONG REVISION STEM, HAD BECOME EXTREMELY LOOSE AND SPUN 180O WITHIN THE HUMERAL CANAL, RESULTING IN THE NEED FOR A SECOND REVISION SURGERY. WHEN THE SURGEON DISSECTED DOWN TO THE IMPLANTS AND REMOVED THE STEM IT HAD NO CEMENT ON IT, AND SURGEON COMPLAINED THE ROUND SMOOTH CEMENTED DESIGN WAS THE ISSUE. A REVISION WAS DONE TO PLACE A FLUTED CEMENTED FRACTURE STEM IN ITS PLACE. OPERATION WAS A SUCCESS, PATIENT LEFT THE OR IN STABLE CONDITION AND SURGEON EXPECTS PATIENT TO DO WELL. EXPLANTS WERE KEPT BY HOSPITAL AS THEY DO NOT ALLOW US TO TAKE THEM.

  Patient problems: Failure of Implant; No Known Impact Or Consequence To Patient

  MAUDE report 9179100 ↗
• InjuryApr 3, 2019Adverse Event Without Identified Device or Use Problem

  PENDING REVISION DUE TO INFECTION. THE PATIENT DID NOT FINISH THEIR COURSE OF ANTIBIOTICS AND IS INFECTED.

  Patient problems: Unspecified Infection

  MAUDE report 8478064 ↗

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-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