Equinoxe 301-09-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885862557681), received between Jun 15, 2020 and May 12, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

10 other recalls cover devices cleared under the same FDA submission (K042021, K061454); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2021Break; Break

  AS REPORTED, DURING INSPECTION OF ERGO PILOT TRAYS BEFORE STERILIZATION, WE DISCOVERED THAT THE BLACK IMPACTOR TIP WAS BROKEN. THIS DID NOT HAPPEN DURING SURGERY, DID NOT AFFECT A PATIENT. IT WAS FOUND IN CPD AFTER SURGICAL USE. DEVICE TO RETURN FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11811578 ↗
• MalfunctionFeb 16, 2021Break; Break

  AS REPORTED, DURING A INITIAL TSA, THE SURGEON WAS INSERTING/IMPACTING THE HUMERAL STEM WHEN THE BLACK PLASTIC WASHER SURROUNDING THE SCREW FRACTURED FALLING ON THE FLOOR RENDERING THE INSERTER USELESS UNTIL REPAIRED. NO PIECES FEEL INTO THE WOUND. THE BROKEN WASHER WAS RETRIEVED AND WILL BE RETURNED WITH THE DEVICE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO SPECIFIC PATIENT INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11331701 ↗
• MalfunctionJun 15, 2020Break; Break

  AS REPORTED, DURING A SURGICAL PROCEDURE OF A (B)(6) FEMALE PATIENT, A RUBBER PIECE BROKE OFF OF A HUMERAL STEM INSERTER. THE PARTS OR PIECES OF THE DEVICE DID NOT FALL INTO THE PATIENT WOUND. THE DEVICE IS TO BE RETURNED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10155076 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K042021, K061454. 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-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-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-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