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Equinoxe 321-25-46Recalls & reported problems

Exactech, Inc. · REAMER, REVERSE SHOULDER, MODULAR, 46mm · Class 2

All models of Equinoxe (305)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862087645), received between Oct 8, 2020 and Feb 2, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (2 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

Device problems

  • Break2

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryFeb 2, 2022Break; Break

    IT WAS REPORTED THAT DURING SURGICAL USE, THE TIP OF THE REAMER BROKE OFF WHILE REAMING THE GLENOID. BROKEN PIECE WAS EASILY REMOVED. NO TIME WAS ADDED TO THE SURGERY AND PATIENT LEFT THE OR IN GOOD HEALTH.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13423577 ↗
  • InjuryOct 8, 2020Break; Break

    AS REPORTED, THE TIP OF A REAMER BROKE IN PILOT HOLE WHILE REAMING THE GLENOID OF THIS MALE PATIENT. THE TIP WAS EASILY RETRIEVED, AND AN X-RAY WAS TAKEN TO VERIFY NOTHING WAS LEFT IN THE PATIENT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO PARTS OR PIECES FELL INTO THE WOUND. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE TO BE RETURNED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10648210 ↗

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-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-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-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-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-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-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-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-0459-2021 · Oct 6, 2020 · Terminated
    Catalog 314-13-23, Equinoxe Cage Glenoid, Posterior Augment, Left, Medium
  • Z-0460-2021 · Oct 6, 2020 · Terminated
    Catalog 314-13-33, Equinoxe Cage Glenoid, Posterior Augment, Right, 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.

Other PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED devices

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Sources and updates

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