Equinoxe 315-25-14Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10885862085368), received between Feb 20, 2020 and Jun 2, 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 18, 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.

• MalfunctionJun 2, 2021Break; Break

  AS REPORTED, DURING A SHOULDER PROCEDURE, AFTER REAMING THE GLENOID THE LARGE PILOT TIPPED REAMER WAS BROKEN. THE INSTRUMENT WAS BROKEN DURING REMOVAL. THE SITE WAS CHECKED FOR PIECES, THE SURGEON CONFIRMED, AND PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION. THE DEVICE IS BEING RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11920816 ↗
• InjuryJun 2, 2021Break; Break

  AS REPORTED, DURING AN INITIAL IMPLANT FOR THIS (B)(6) Y/O FEMALE PATIENT, THE SURGEON HAD SEQUENTIALLY REAMED THE GLENOID WITH XS, SM, AND MED PRIMARY PILOT TIPPED GLENOID REAMERS. AS THE SURGEON STARTED TO USE THE LARGE REAMER, IT BROKE ACTUAL DOMED REAMER SECTION LOOSE FROM THE "CENTER" SECTION, WHICH ATTACHES TO THE REAMER HANDLE, AND THE "CENTER" PIECE SUBSEQUENTLY CREATED A LARGE HOLE IN THE CENTER OF THE GLENOID, WHICH IS WHERE THE SURGEON HAD INTENDED TO PLACE THE CAGE PORTION OF THE CAGED GLENOID. THERE WERE PIECES WERE REMOVED. THE SURGEON PROCEEDED WITH THE PRIMARY TOTAL SHOULDER REPLACEMENT. THERE WAS A 15-30-MINUTE DELAY. NO ADVERSE EVENT REPORTED DUE TO DELAY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11920812 ↗
• InjuryMar 3, 2021Break; Break

  AS REPORTED, DURING A PROCEDURE ON A MALE PATIENT, THE REAMER BROKE WHILE REAMING THE GLENOID. ALL PIECES WE RETRIEVED AND VERIFIED BY X RAY. NO TIME WAS ADDED TO THE CASE AND THE PATIENT WASN¿T HARMED. 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 11404696 ↗
• MalfunctionAug 13, 2020Break; Break

  AS REPORTED, DURING A PRIMARY PROCEDURE ON THIS (B)(6) Y/O MALE PATIENT, THE CENTER PIECE OF THE PRIMARY LARGE PILOT REAMER DETACHED FROM THE OUTER CAGE DURING REAMING. IT SLIGHTLY ENLARGED THE CENTER CAGE HOLE, REQUIRING CEMENTING OF THE GLENOID CAGE. EXTRA TIME HAD TO BE TAKEN TO CEMENT THE CENTER CAGE OF PROSTHESIS, APPROXIMATELY 5-15 MINS. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. INSTRUMENT TO BE RETURNED. NO PARTS OR PIECES OF THE DEVICE FELL INTO THE PATIENT WOUND SITE. (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10403606 ↗
• MalfunctionFeb 20, 2020Break; Break

  AS REPORTED, THE SURGEON WAS TRYING TO USE THE LARGE PILOT REAMER IN A MUSCLED PATIENT AND CLIPPED THE REAMER ON HIS POSTERIOR RETRACTOR. THE REAMER CRACKED ON IMPACT. NO ADVERSE IMPACT ON THE PATIENT. WE USED THE SMALLER REAMER TO CONTINUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9734688 ↗

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-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-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-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-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-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-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-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-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-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-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.