Unity Total Knee System 112.001.34Recalls & 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.

2 other recalls cover devices cleared under the same FDA submission (K113060); 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. Oct 13, 2023Open, Classified

   Potential for Unity CR Inserts Right size 6 from batch 529803 to be incorrectly labelled as Unity CR Inserts Right size 7 from batch 532405 and visa versa.

   Z-0214-2024 · Root cause: Process change control · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K113060. One submission often covers many models, so check the product and lot details in each record.

• Z-0213-2024 · Oct 13, 2023 · Open, Classified
  Unity CR Femur Right, Size 6, Model Number 112.001.32 Primary and revision total knee arthroplasty
• Z-0273-2023 · Oct 31, 2022 · Terminated
  Unity Total Knee System. Used for knee prosthesis in total knee replacement