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Alteon 01-030-40-0640Recalls & reported problems

Exactech, Inc. · Alteon Cup · Class 2 · Implant

All models of Alteon (135)

Data updated Oct 18, 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
0
Deaths reported
0
Injuries reported
0
Recalls naming it
2

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

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 18, 2026.

Recalls naming this device

  1. Dec 31, 2024Class IIOpen, Classified

    Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.

    Z-1167-2025 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

  2. Nov 21, 2023Class IIOpen, Classified

    Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.

    Z-0578-2024 · Root cause: Packaging change control · Recall details · FDA record ↗

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

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Sources and updates

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