Conformis, Inc.: Medical Device Recall in 2019 - (Recall #: Z-1108-2019)

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 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.

Product Classification:

Class II

Date Initiated: December 3, 2018

Date Posted: April 17, 2019

Recall Number: Z-1108-2019

Event ID: 82100

Reason for Recall:

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

Status: Terminated

Product Quantity: 2

Code Information:

Serial Numbers 0432428 and 0432212

Distribution Pattern:

Worldwide Distribution - US Nationwide in the state: NC and the country of: Hungary.

Voluntary or Mandated:

Voluntary: Firm initiated