Equinoxe 301-03-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10885862079619), received between Sep 23, 2020 and Feb 7, 2023 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 7, 2023Break; Fracture; Detachment of Device or Device Component; Break; Fracture; Detachment of Device or Device Component

  AS REPORTED, DURING SURGICAL USE, THE METAL BAR IN THE BROACH HANDLE FELL OUT WHEN IMPACTING. THE CASE WAS DELAYED BY 10-15 MINUTES DUE TO X-RAY TO SEE IF THE BAR WAS INSIDE THE PATIENT. PER THE REP, THE METAL BAR WAS NOT IN THE PATIENT. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16312998 ↗
• MalfunctionJun 30, 2022Break; Break

  DURING SET UP, AS THE BROACH HANDLE WAS BEING REMOVED, THE SPRING AND PIN FROM THE BROACH ATTACHMENT BUTTON CAME OUT OF THE INSTRUMENT. NO PIECES OR PARTS FELL INTO THE PATIENT WOUND SITE. THERE WAS NO SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO PATIENT INFORMATION AVAILABLE. DEVICE IS RETURNING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14878817 ↗
• MalfunctionApr 6, 2021Break; Break

  DURING THIS FEMALE PATIENT¿S INITIAL PROCEDURE, WHILE USING THE BROACH AND BROACH HANDLE TOGETHER, THE LOCKING BUTTON WAS DAMAGED AND FELL TO THE FLOOR. THE SMALL STICK AND SPRING THAT THE BUTTON WAS ATTACHED TO COULD BE SEEN ON THE FLOOR. WE CHECKED WITH THE C-ARM JUST IN CASE OF FRAGMENTS AND MADE SURE THERE WERE NO PIECES INSIDE. THE OPERATION WAS REPLACED BY STEM TRIAL INSTEAD OF BROACH, AND THERE WAS A SLIGHT DELAY, BUT THE OPERATION WAS WELL COMPLETED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE WILL BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11618153 ↗
• InjuryNov 14, 2020Break; Break

  AS REPORTED, DURING A SHOULDER PROCEDURE ON A (B)(6) MALE, A WASHING WAS PERFORMED WITH A PULSAVAC AND A BROKEN PIECE OF THE MODULAR BROACH HANDLE WAS FOUND IN THE WOUND. THIS BREAKAGE WAS NOT IDENTIFIED BEFORE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES ARE TO BE RETURNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10841090 ↗
• InjurySep 23, 2020Break; Break

  AS REPORTED DURING A SHOULDER PROCEDURE, WHILE REMOVING BROACH FROM HUMERUS, THE HOLDING PIN IN THE BUTTON OF THE BROACH HANDLE CAME OUT. ALL PARTS WERE RETRIEVED BUT THE HOLDING PIN WAS LOST DURING THE WASH CYCLE. NO DELAY TO SURGERY, SECOND BROACH HANDLE WAS USED FOR THE REMAINDER OF THE CASE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE WILL BE RETURNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10574246 ↗

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-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-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-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