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Equinoxe 314-02-24Recalls & reported problems

Exactech, Inc. · Class 2 · Implant

All models of Equinoxe (305)

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

2 open recalls name 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
2

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862175076), received between Jul 9, 2021 and Jul 9, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

2 FDA recall records name this device's identifier, 2 still open.

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-1407-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

  2. 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-1406-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Device problems

  • Device Dislodged or Dislocated1

Patient problems

  • Failure of Implant1

Recent adverse event reports

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

  • InjuryJul 9, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

    AS REPORTED, THIS (B)(6) Y/O MALE PATIENT PRESENTED APPROXIMATELY 3 MOS POSTOP THE INITIAL L TSA FOR FOLLOW-UP AFTER SURGERY AND X-RAYS REVEALED POLY COMPONENT WAS NO LONGER IN GLENOID. CENTRAL PEG DID APPEAR TO STILL BE IN PLACE. A POP WAS FELT DURING ONE PHYSICAL THERAPY APPOINTMENT. SURGEON REMOVED POLY FROM PATIENT VIA AN ARTHROSCOPIC AND MINI OPEN TECHNIQUE. GLENOID BECAME LOOSE AND FREE FLOATING IN JOINT CENTRAL PEG REMAINED IN PATIENT AND BROKE FROM THE REST OF THE COMPONENT. PATIENT HAS REQUESTED IMPLANT (PRODUCT NOT RETURNING). PICTURES FROM PROCEDURE AND PICTURES OF REMOVED POLY ARE AVAILABLE. PATIENT HAS REQUESTED EXPLANT. EVENT OCCURRED AFTER PRIMARY SURGERY. NO REPORTED DELAY/PROLONGATION. DEVICE WILL NOT RETURN DUE TO PATIENT REQUESTED TO KEEP IT.

    Patient problems: Failure of Implant

    MAUDE report 12141843 ↗

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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