iTotal CR Knee Replacement System (Conformis) – Insert Fit Problem (2019)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
iTotal CR Knee Replacement System Model Number: TCR-111-1111-010102 - 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.
Brand
Conformis, Inc.
Lot Codes / Batch Numbers
Serial Number: 0450585
Products Sold
Serial Number: 0450585
Conformis, Inc. is recalling iTotal CR Knee Replacement System Model Number: TCR-111-1111-010102 - Product Usage: The iTotal CR due to Medial and lateral polyethylene inserts did not securely fit into the cobalt chrome tray implant.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Medial and lateral polyethylene inserts did not securely fit into the cobalt chrome tray implant.
Recommended Action
Per FDA guidance
Conformis contacted surgeon via phone on 10/16/19 with the replacement details. Replacement inserts that match the implanted tibial tray interlock geometry were shipped to the affected customer.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026