iTotal Identity CR Knee Replacement System (with CS Insert) TCR023060A01Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M572TCR023060A011), received between Oct 17, 2025 and Oct 17, 2025 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K210809); 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.

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.

• InjuryOct 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT RETURNED TO THE SURGEON REPORTING FLEXION INSTABILITY. THE SURGEON HAS REQUESTED A REVISION POLY LINER WITH ADDITIONAL CONSTRAINT.

  Patient problems: Limb Pain

  MAUDE report 23327790 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K210809. One submission often covers many models, so check the product and lot details in each record.

• Z-0899-2022 · Feb 22, 2022 · Completed
  iTotal Identity Posterior Stabilised (PS) Knee Replacement System Model Number: TPS-301-1113-020101