Equinoxe 301-03-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10885862079626), received between Aug 6, 2020 and Aug 30, 2022 — classified as 3 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 30, 2022Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, WHEN REMOVING A TRIAL STEM USING THE STEM EXTRACTOR, THE SURGEON ACCIDENTALLY STRUCK THE RETROVERSION ROD, CAUSING THE SCREW THREAD TO SNAP OFF WITHIN THE STEM EXTRACTOR TOOL. NO FRAGMENTS, PIECES OR PARTS FELL INTO PATIENT WOUND. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE IS AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15325152 ↗
• InjuryJul 7, 2022Break; Break

  IT WAS REPORTED THAT THE DEVICE BROKE. SURGEON IMPACTED ON RETROVERSION HANDLE WHILE REMOVING BROACH. NO PARTS OR PIECES FELL INTO THE PATIENTS WOUND. THERE WAS NO SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14943981 ↗
• MalfunctionJun 22, 2022Break; Break

  IT WAS REPORTED THAT DURING SURGICAL USE, THE SURGEON BACK SLAPPED THE BROACH HANDLE AND HIT THE VERSION HANDLE CAUSING IT TO BREAK OFF AT THE THREADS. NO PARTS WERE LOST. NOTHING FELL INTO THE WOUND. THE PATIENT WASN¿T EFFECTED. THERE WAS NO DELAY TO THE CASE. WE OPENED ANOTHER SET TO USE ANOTHER VERSION HANDLE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14781712 ↗
• MalfunctionApr 9, 2021Break; Break

  AS REPORTED, THE RETROVERSION HANDLE SNAPPED OFF STEM INSERTER/EXTRACTOR DUE TO BEING STRUCK BY MALLET BY DOCTOR. THE THREADED BIT IS STILL IN LEFT SIDE OF INSERTER. NO PIECES EXCEPT WHAT WAS STUCK IN THE HANDLE. NO DELAY. DEVICE WILL RETURN FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11640341 ↗
• MalfunctionApr 9, 2021Break; Break

  AS REPORTED, DURING A PROCEDURE ON THIS (B)(6) MALE, THE SURGEON WAS REMOVING THE STEM TRIAL AND HIT THE RETROVERSION HANDLE WITH A MALLET, CAUSING HANDLE TO BREAK OFF. NO PIECES FELL INTO SURGICAL SITE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE TO BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11640116 ↗
• InjuryFeb 23, 2021Break; Break

  AS REPORTED, DURING REMOVAL OF TRIAL STEM THE SURGEON HIT THE VERSION BAR THAT WAS ON THE STEM EXTRACTOR CAUSING IT TO SHEAR OFF. ALL PARTS WERE REMOVED FROM THE PATIENT AND NOTHING WAS LEFT INSIDE. DEVICE WILL RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11364438 ↗
• MalfunctionJan 12, 2021Break; Break

  AS REPORTED, A BROKEN VERSION ROD WITH THE THREADS GONE WAS DISCOVERED WHEN PICKING UP INSTRUMENTS FROM PROCESSING. SPECIFIC CASE AND PATIENT INFORMATION IS UNKNOWN. DEVICE TO BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11153730 ↗
• MalfunctionDec 28, 2020Break; Break

  AS REPORTED, WHEN INSPECTING THE KIT ON ITS RETURN FROM A CUSTOMER, IT WAS NOTICED THAT PART # 301-03-10 HAD BEEN PLACED IN A BAG WITH A NOTE SAYING IT WAS BROKEN FROM CSSD AT (B)(6). ON CLOSER INSPECTION IT WAS NOTICED THAT PART # 301-07-10 WAS ALSO DAMAGED AND HAD THE BROKEN BIT FROM PART # 301-03-10 STILL STUCK IN THE HANDLE. THE CUSTOMER WAS UNABLE TO GIVE AN EXPLANATION AS TO WHEN AND HOW IT BROKE. DEVICES TO BE RETURNED. IT IS UNKNOWN IF A PATIENT WAS INVOLVED OR IF THE BREAK HAPPENED WHILE CLEANING.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11076071 ↗
• InjuryAug 6, 2020Break; Break

  AS REPORTED, DURING IMPLANTATION OF THE HUMERAL STEM THE RETROVERSION ROD THREAD SNAPPED AND BECAME DETACHED. BOTH PIECES EASILY RECOVERED. NO PATIENT IMPACT. DEVICES TO BE RETURNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10375763 ↗

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 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-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-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-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-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