Equinoxe 315-25-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10885862085375), received between Mar 9, 2020 and Mar 24, 2021 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (5 reports).

18 other recalls cover devices cleared under the same FDA submission (K042021, K093430, K113309); 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.

• InjuryMar 24, 2021Break; Break

  DURING A PROCEDURE, THE REAMER BROKE WHILE REAMING THE GLENOID. ALL PARTS WERE RETRIEVED, AND NOTHING WAS LEFT IN THE WOUND. THE PATIENT WASN¿T EFFECTED AND THE CASE WASN¿T PROLONGED. AN X RAY WAS TAKEN SHOWING NO PARTS WERE LEFT IN THE PATIENT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE TO BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11561775 ↗
• InjuryMar 17, 2021Break; Break

  AS REPORTED, THE PILOT REAMER BROKE WHILE REAMING THE GLENOID OF THIS MALE PATIENT. ALL PIECES WERE RETRIEVED AND CONFIRMED BY X RAY. NO TIME WAS ADDED TO THE PROCEDURE AND THE PATIENT WASN¿T HARMED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11504663 ↗
• MalfunctionMar 16, 2021Break; Break

  AS REPORTED, THE SURGEON WAS REAMING THE GLENOID AS PREPARATION FOR THE IMPLANT. WHEN THE SURGEON WAS USING HIS FINAL REAMER FOR THE XL GLENOID IMPLANT, THE REAMER CAUGHT PART OF A RETRACTOR, AND BROKE. THIS WAS UNDERSTOOD BY THE SURGEON THAT THE REAMER WAS BEING PUSHED WITH SIGNIFICANT FORCE, AND WHEN IT CAUGHT A SOLID PIECE OF THE METAL THE REAMER THE FORCE BEING PUT ON THE REAMER CAUSED IT TO BREAK. THE PATIENT WAS NOT INJURED DUE TO THIS, AND THERE WAS ONLY A MINIMAL DELAY TO THE SURGERY. THE PATIENT WAS NOT HARMED IN THE PROCESSED. THERE WERE NO PARTS OR PIECES THAT FELL INTO THE OPEN WOUND. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL RETURN FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11496839 ↗
• MalfunctionDec 8, 2020Break; Break

  AS REPORTED, THE SURGEON WAS REAMING THE GLENOID, WHICH WAS A VERY LARGE GLENOID, AND THE REAMER CAUGHT A TIP OF BONE WHILE BEING RUN AT FULL SPEED AND BROKE. THE PATIENT WAS NOT AFFECTED OR HARMED DURING THE INCIDENT. THE ITEM IS BEING REPLACED. THERE WAS NO SIGNIFICANT DELAY TO THE CASE. THE PATIENT WAS FINE. THERE WAS NO HARM TO THE PATIENT. DEVICE TO BE RETURNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10967273 ↗
• MalfunctionMar 9, 2020Break; Break

  AS REPORTED, DURING A REVERSE TOTAL SHOULDER ON A (B)(6) Y/O MALE PATIENT, THE GLENOID HAD AN EXTERIOR LIP TO IT AND THE SURGEON NEEDED A LARGER REAMER JUST TO CORRECTLY REAM THIS LIP DOWN. WHEN REAMING, THE REAMER CAME APART (DESTROYED) FROM THE MIDDLE. ALL PIECES WERE REMOVED FROM THE PATIENT AND ACCOUNTED FOR. NO INJURY OCCURRED TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9805014 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K042021, K093430, K113309. 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-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-1414-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number
• Z-1415-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Numbe
• 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-1412-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 3
• 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-1413-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47
• Z-0884-2021 · Nov 9, 2020 · Open, Classified
  Equinoxe Humeral Stem, Primary, Press Fit, 11mm
• Z-0460-2021 · Oct 6, 2020 · Terminated
  Catalog 314-13-33, Equinoxe Cage Glenoid, Posterior Augment, Right, Medium
• Z-0459-2021 · Oct 6, 2020 · Terminated
  Catalog 314-13-23, Equinoxe Cage Glenoid, Posterior Augment, Left, Medium
• Z-0414-2018 · Aug 31, 2017 · Terminated
  Equinoxe Cage, Glenoid, Alpha, Small Product Usage: The Equinoxe Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases or fractures of t

…and 3 more.