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 cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral, or bicompartmental prosthesis.
FDA Recall Z-1108-2019 · Posted None
Recalling FirmConformis, Inc.
Recall StatusTerminated
Product CodeJWH
Date Initiated2018-12-03
Date Terminated2020-06-26
Product Quantity2
Reason for Recall
The kits were prepared with incorrect patient ID labels and may contain incorrect components.
Firm Action
Customers were contacted via email on 12/3/18. Customers were contacted via email on 12/3/18. The customer was instructed to return the product.
Root Cause
Labeling mix-ups
Distribution Pattern
Worldwide Distribution - US Nationwide in the state: NC and the country of: Hungary.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.