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Equinoxe 314-06-23Recalls & reported problems

Exactech, Inc. · Class 2 · Implant

All models of Equinoxe (305)

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

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
1

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862228314), received between Mar 28, 2022 and Mar 28, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K121220); 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.

Recalls naming this device

  1. Mar 6, 2024Open, Classified

    The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).

    Z-1410-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Device problems

  • Loosening of Implant Not Related to Bone-Ingrowth1
  • Patient Device Interaction Problem1

Patient problems

  • Inadequate Osseointegration1
  • Insufficient Information1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryMar 28, 2022Patient Device Interaction Problem; Loosening of Implant Not Related to Bone-Ingrowth; Patient Device Interaction Problem; Loosening of Implant Not Related to Bone-Ingrowth

    AS REPORTED BY THE EQUINOXE SHOULDER STUDY, A PATIENT RECEIVED A LEFT ANATOMIC TOTAL SHOULDER SURGERY AND NOW FOUR YEARS POST-OPERATIVE IS EXPERIENCING ASEPTIC GLENOID LOOSENING. IT IS UNKNOWN WHAT, IF ANY, ACTION WAS TAKEN. THE CASE REPORT FORM INDICATES THIS EVENT IS DEFINITELY NOT RELATED TO DEVICES AND DEFINITELY RELATED TO PROCEDURE. THE ADVERSE EVENT SUBMISSION FROM THE STUDY STATES THAT THE PATIENT NEEDS A REVISION. ACCORDING TO THE INFORMATION PROVIDED, THE PATIENT HAS DEGENERATIVE ARTHRITIS IN THEIR LEFT GLENOHUMERAL JOINT WITH POSTERIOR EROSION. THE COMPANY IS NOT AWARE OF A REVISION AT THE TIME OF THIS INVESTIGATION. NO OTHER INFORMATION PROVIDED.

    Patient problems: Inadequate Osseointegration; Insufficient Information

    MAUDE report 13932511 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121220. One submission often covers many models, so check the product and lot details in each record.

  • Z-1411-2024 · Mar 6, 2024 · Open, Classified
    Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 16o, RIGHT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-06-32, b) 41, 44, 47, 50 head,

Other Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented devices

All Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented devices →

Sources and updates

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