Conformis, Inc.: Medical Device Recall in 2022 - (Recall #: Z-0899-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

iTotal Identity Posterior Stabilised (PS) Knee Replacement System Model Number: TPS-301-1113-020101

Product Classification:

Class II

Date Initiated: February 22, 2022

Date Posted: April 20, 2022

Recall Number: Z-0899-2022

Event ID: 89903

Reason for Recall:

Incorrect tibial base plate implant packaged in kit

Status: Completed

Product Quantity: 1 unit

Code Information:

Serial Number: 0496242 UDI: M572TPS3011113011

Distribution Pattern:

Voluntary or Mandated:

Voluntary: Firm initiated