Unity Total Knee System 112.016.85Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05055343875391), received between Jul 31, 2026 and Jul 31, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Unstable” (1 report).

3 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

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

• InjuryJul 31, 2026Unstable

  Unity revision of the PS Insert after approx. 2 years due to instability.

  Patient problems: Joint Laxity

  MAUDE report 50098398 ↗

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-0214-2024 · Oct 13, 2023 · Open, Classified
  Unity Total Knee System, Model Number 112.001.34. Primary and revision total knee arthroplasty
• 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