Skip to content

Equinoxe 310-62-47Recalls & reported problems

Exactech, Inc. · Class 2 · Implant

All models of Equinoxe (305)

Data updated Oct 18, 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 10885862556134), received between Sep 29, 2022 and Apr 17, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 1 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Insufficient Device Problem Information1
  • Naturally Worn1

Patient problems

  • Failure of Implant1
  • Insufficient Information1
  • Pain1

Recent adverse event reports

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

  • InjuryApr 17, 2025Naturally Worn; Naturally Worn

    IT WAS REPORTED THAT THIS PATIENT'S RIGHT SHOULDER WAS REVISED. PATIENT HAD PAIN THAT LEAD TO X-RAYS. OBSERVATION SHOWED MIGRATION ON THE PE AND THE PERIPHERAL PEGS. ONLY THE CENTRAL PEG WAS STILL IN PLACE, IT WAS INITIALLY CEMENTED. THE PATIENT WAS CONVERTED TO A REVERSE WITH A BASEPLATE+10MM AND BONE GRAFT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Patient problems: Pain

    MAUDE report 21855972 ↗
  • InjurySep 29, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

    IT WAS REPORTED THAT THIS 71 Y/O FEMALE PATIENT WAS CONVERTED A RIGHT STEMLESS ANATOMIC SHOULDER TO A REVERSE TOTAL SHOULDER. REASON FOR THIS REVISION WAS NOT REPORTED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PRODUCT IS NOT AVAILABLE FOR RETURN.

    Patient problems: Failure of Implant; Insufficient Information

    MAUDE report 15503272 ↗

Other Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained devices

All Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page