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Alteon 01-030-40-0736Recalls & 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

1 open recall names 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
1

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862549709), received between Jun 23, 2021 and Jun 23, 2021 — classified as 1 injury.

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K182502); they may or may not involve this specific model.

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 ↗

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Joint Dislocation1

Recent adverse event reports

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

  • InjuryJun 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    AS REPORTED, A PATIENT HAD A RIGHT ANTERIOR HIP REPLACEMENT ON (B)(6) 2021 THE PATIENT DISLOCATION ANTERIORLY WHILE BENDING BACKWARDS AND PUSHING HIS HIPS FORWARDS. THE MALE PATIENT WAS REVISED, AND THE CUP WAS REMOVED SO THAT HE COULD IMPLANT A CUP WITH DUAL MOBILITY. UTILIZING LATERAL STANDING AND SITTING XRAYS, THE SURGEON DETERMINED THAT THE PATIENT HAD AN ANATOMICALLY FUSED SPINE AND HIS HIP REPLACEMENT IMPINGED POSTERIORLY DUE TO HIS LACK OF PELVIC MOTION AT THE L5-S11 JOINT.

    Patient problems: Joint Dislocation

    MAUDE report 12052359 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K182502. One submission often covers many models, so check the product and lot details in each record.

  • Z-0578-2024 · Nov 21, 2023 · Open, Classified
    Exactech Alteon Hip XLE Liner, Catalog Numbers: a) 01-030-40-0636, b) 01-030-40-0640, c) 01-030-42-0536

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

All Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented devices →

Sources and updates

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