Conformis, Inc.: Medical Device Recall in 2020 - (Recall #: Z-1628-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

iTotal PS Knee Replacement System, Model No. TPS-111-1111-010101, (ITOTAL PS IPOLY IMPLANT KIT LEFT) 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: February 3, 2020

Date Posted: April 8, 2020

Recall Number: Z-1628-2020

Event ID: 85108

Reason for Recall:

A limited number of tibial trays were labeled with an incorrect serial number and were delivered to the wrong customer accounts.

Status: Terminated

Product Quantity: 2

Code Information:

0460018 0460118

Distribution Pattern:

US Nationwide distribution in the states of LA, NY, TN.

Voluntary or Mandated:

Voluntary: Firm initiated