Conformis, Inc.: Medical Device Recall in 2019 - (Recall #: Z-0672-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: October 25, 2019

Date Posted: December 18, 2019

Recall Number: Z-0672-2020

Event ID: 84315

Reason for Recall:

Medial and lateral polyethylene inserts did not securely fit into the cobalt chrome tray implant.

Status: Terminated

Product Quantity: 1 unit

Code Information:

Serial Number: 0450585

Distribution Pattern:

US Nationwide distribution in the state of GA.

Voluntary or Mandated:

Voluntary: Firm initiated