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Vanguard M Partial Knee System US154722Recalls & reported problems

Biomet Orthopedics, LLC · Class 2 · Implant

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

Summary

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

1 FDA recall record name this device's identifier.

1 other recall cover devices cleared under the same FDA submission (K021621, K042093); 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Apr 17, 2020Terminated

    Potential presence of elevated endotoxin levels that exceed the specification limit

    Z-2155-2020 · Root cause: Process control · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K021621, K042093. One submission often covers many models, so check the product and lot details in each record.

  • Z-1798-2015 · Apr 22, 2015 · Terminated
    Vanguard M Unicondylar Tibial Trial For use during knee joint replacement.

Other PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER devices

All PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.