U2 Total Knee System 9323-5515Recalls & reported problems

Summary

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

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

1 other recall cover devices cleared under the same FDA submission (K082424); 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. May 20, 2026Class IIOpen, Classified

   Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.

   Z-2883-2026 · Root cause: Process design · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K082424. One submission often covers many models, so check the product and lot details in each record.

• Z-1129-2018 · Nov 24, 2017 · Terminated
  U2 Total Knee System Tibial Insert, PSA, #1, 21mm Thick Catalogue number 2303-5016 The U2 Total Knee system is indicated in knee arthroplasty for reduction or relief of pain and/o