Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1108-2019 — iTotal CR Total Knee Replacement System, TCR-121-1111 (Catalog No.) / TCR-121-1111-010102 (Model No.) M5725INT0600010 (Model No.) Product Usage: The iTotal CR Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions

U.S. FDA — Device Enforcement · United States · 2018-12-03 · Class II

AI-assisted, human-edited — this page is drafted with AI from public-source data, then reviewed before publication. How we use AI →

Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1108-2019
Date of alert: 2018-12-03
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Conformis, Inc.
Product category: device
Product type: Devices

Reported risk: The kits were prepared with incorrect patient ID labels and may contain incorrect components.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Related