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.
- Company
- Conformis, Inc.
- Recall Initiated
- October 25, 2019
- Terminated
- May 20, 2020
- Recall Number
- Z-0672-2020
- Quantity
- 1 unit
- Firm Location
- Billerica, MA
Reason for Recall
Medial and lateral polyethylene inserts did not securely fit into the cobalt chrome tray implant.
Distribution
US Nationwide distribution in the state of GA.
Lot / Code Info
Serial Number: 0450585
Root Cause
Under Investigation by firm
Action Taken
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.
More recalls by Conformis, Inc.
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