Equinoxe 301-07-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10885862079701), received between Oct 24, 2022 and Nov 30, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 reports).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 30, 2022Break; Break

  IT WAS REPORTED THAT THIS INSTRUMENT COULD HAVE BROKEN DURING SURGERY. HOWEVER, THE BREAKAGE HAS BEEN NOTICED AT THE RECOVERY OF THE INSTRUMENTATION-SET BY OUR LOGISTICS DEPT., AFTER THE CLEANING REALIZED BY THE STERILIZATION TEAM OF THE HOSPITAL. NO INFORMATION HAS BEEN RECEIVED FROM THE HOSPITAL REGARDING THIS ISSUE AND XNOV IP DIDN'T RECEIVE ANY REQUEST FOR COMPLEMENTARY INFORMATION REGARDING THIS ISSUE AS WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15885310 ↗
• MalfunctionNov 27, 2022Break; Break

  AS REPORTED, THE INSTRUMENT COULD HAVE BEEN BROKEN DURING THE SURGERY. HOWEVER, THE BREAKAGE WAS NOTICED AT THE RECOVERY OF THE INSTRUMENTATION SET BY THE LOGISTICS DEPT., AFTER THE CLEANING REALIZED BY THE STERILIZATION TEAM OF THE HOSPITAL. NO INFORMATION HAS BEEN RECEIVED FROM THE HOSPITAL REGARDING THIS ISSUE AND XNOV IP DIDN'T RECEIVE ANY REQUEST FOR COMPLEMENTARY INFORMATION REGARDING THIS ISSUE AS WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15867343 ↗
• MalfunctionOct 24, 2022Break; Break

  THE INSTRUMENT COULD HAVE BEEN BROKEN DURING THE SURGERY. HOWEVER, THE BREAKAGE HAS BEEN NOTICED AT THE RECOVERY OF THE INSTRUMENTATION-SET BY OUR LOGISTICS DEPT., AFTER THE CLEANING REALIZED BY THE STERILIZATION TEAM OF THE HOSPITAL. NO INFORMATION HAS BEEN RECEIVED FROM THE HOSPITAL REGARDING THIS ISSUE AND XNOV IP DIDN¿T RECEIVE ANY REQUEST FOR COMPLEMENTARY INFORMATION REGARDING THIS ISSUE AS WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15660493 ↗
• MalfunctionOct 24, 2022Break; Break

  THE INSTRUMENT COULD HAVE BEEN BROKEN DURING THE SURGERY. HOWEVER, THE BREAKAGE HAS BEEN NOTICED AT THE RECOVERY OF THE INSTRUMENTATION-SET BY OUR LOGISTICS DEPT., AFTER THE CLEANING REALIZED BY THE STERILIZATION TEAM OF THE HOSPITAL. NO INFORMATION HAS BEEN RECEIVED FROM THE HOSPITAL REGARDING THIS ISSUE AND XNOV IP DIDN¿T RECEIVE ANY REQUEST FOR COMPLEMENTARY INFORMATION REGARDING THIS ISSUE AS WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15660040 ↗

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 Component: N
• 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-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-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-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