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Alteon 01-010-24-4195Recalls & reported problems

Exactech, Inc. · Class 2 · Implant

All models of Alteon (135)

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

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862281951), received between Sep 16, 2019 and Sep 16, 2019 — classified as 1 injury.

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

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Bacterial Infection1
  • Unspecified Infection1

Recent adverse event reports

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

  • InjurySep 16, 2019Adverse Event Without Identified Device or Use Problem

    INDEX SURGERY: (B)(6) 2019. FOUR DAYS LATER ON (B)(6) 2019, CULTURES REPORT POSITIVE FOR E. FAECIUM, WITH INFECTIOLOGY, ANTIBIOTIC MANAGEMENT AND PROSTHESIS RETENTION PROTOCOL ARE INITIATED. THE CASE REPORT FORM INDICATES THIS EVENT IS DEFINITELY DOT RELATED TO DEVICES AND DEFINITELY RELATED TO PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES.

    Patient problems: Bacterial Infection; Unspecified Infection

    MAUDE report 9070029 ↗

Other Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented devices

All Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented devices →

Sources and updates

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