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Equinoxe 319-00-10Recalls & reported problems

Exactech, Inc. · STEMLESS SPRING INSERTER · Class 2

All models of Equinoxe (305)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862538697), received between Mar 8, 2023 and Mar 8, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

Most reported problems

Device problems

  • Detachment of Device or Device Component1

Patient problems

  • Insufficient Information1

Recent adverse event reports

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

  • MalfunctionMar 8, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED THAT DURING A STEMLESS SURGERY, THE STEMLESS SPRING INSERTER DIS-ASSEMBLED. THERE WAS LESS THAN A 5 MINUTE SURGICAL DELAY WITH NO PATIENT IMPACT AS A RESULT. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE IS AVAILABLE FOR RETURN.

    Patient problems: Insufficient Information

    MAUDE report 16508342 ↗

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

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