Equinoxe 315-07-06Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10885862251824), received between May 8, 2020 and May 13, 2024 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (7 reports).

10 other recalls cover devices cleared under the same FDA submission (K042021, K093430); 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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMay 13, 2024Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT AFTER CEMENTING IN A CAGED GLENOID THE SURGEON SWITCHED FROM THE SPIDER IMPACTOR TO THE NORMAL IMPACTOR TO PRESSURISE THE IMPLANT. AFTER APPROX 5-10 MINUTES HE IMPACTED THE HANDLE ONCE MORE WITH A MALLET AND THE TIP BROKE. HE COLLATED ALL THE BROKEN PARTS MADE SURE HE GOT EVERYTHING OUT, WASHED OUT THE WOUND AND PROCEEDED WITH THE REST OF THE OPERATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19296351 ↗
• MalfunctionDec 21, 2021Break; Break

  AS REPORTED, DURING THE SURGEON¿S ROUTINE IMPACTION OF AN ANATOMIC GLENOID IMPLANT, THE IMPACTOR TIP BROKE INTO TWO PIECES WHICH WERE BOTH EASILY RETRIEVED. NOTHING FELL INTO THE WOUND SITE. THE (B)(6) MALE WAS NOT AFFECTED BY THE BREAK. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE IS TO BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13052787 ↗
• InjuryFeb 18, 2021Break; Break

  DURING A SHOULDER PROCEDURE ON A MALE PATIENT, THE TRI DRIVE COLLAR BROKE DURING GLENOID REAMING. CAUSING THE NEED TO CHANGE REAMER HANDLE AND REMOVE BALL BEARING AND RING FROM OPEN WOUND. DURING THE SAME PROCEDURE, WHEN IMPACTING THE GLENOID, THE GLENOID IMPACTOR TIP BROKE AND ALSO HAD PARTS REMOVED FROM WOUND. NO HEALTH COMPLICATIONS FROM EXPERIENCE, JUST SURGICAL DELAY. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES WILL RETURN. TRI DRIVE (315-25-00) STATED ON EXPERIENCE REPORT IS BEING CAPTURED UNDER (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11342061 ↗
• InjuryFeb 18, 2021Break; Break

  DURING A SHOULDER PROCEDURE ON A MALE PATIENT, THE TRI DRIVE COLLAR BROKE DURING GLENOID REAMING. CAUSING THE NEED TO CHANGE REAMER HANDLE AND REMOVE BALL BEARING AND RING FROM OPEN WOUND. DURING THE SAME PROCEDURE, WHEN IMPACTING THE GLENOID, THE GLENOID IMPACTOR TIP BROKE AND ALSO HAD PARTS REMOVED FROM WOUND. NO HEALTH COMPLICATIONS FROM EXPERIENCE, JUST SURGICAL DELAY. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES WILL RETURN. TRI DRIVE (315-25-00) STATED ON EXPERIENCE REPORT IS BEING CAPTURED UNDER CASE (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11342057 ↗
• MalfunctionJun 25, 2020Break; Break

  THE GLENOID IMPACTOR TIP IS BROKEN. THE PATIENT IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10194606 ↗
• InjuryMay 8, 2020Break; Break

  AS REPORTED, DURING A PROCEDURE ON A (B)(6) Y/O MALE PATIENT, THE SURGEON IMPACTED THE GLENOID COMPONENT WITH THE PLASTIC BLACK TIP, IT FRACTURED IN HALF. THE BROKEN IMPACTOR TIP PIECES WERE REMOVED FROM THE WOUND. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE IS AVAILABLE FOR RETURN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10038630 ↗
• InjuryMay 8, 2020Break; Break

  AS REPORTED, DURING A SHOULDER PROCEDURE ON THIS (B)(6) Y/O MALE, THE SECONDARY GLENOID IMPACTOR BROKE WHILE IMPACTING THE GLENOID. ALL BROKEN PIECES WERE REMOVED FROM THE WOUND. THE BROKEN PIECE WAS THROWN AWAY AFTER THE CASE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10038532 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K042021, K093430. 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 Compone
• 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 Compone
• 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
• 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-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-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