Conformis, Inc.: Medical Device Recall in 2020 - (Recall #: Z-2849-2020)

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:

Conformis iTotal Cruciate Retaining (CR) Knee Replacement System- Orthopedic Implant Cat: TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFT)

Product Classification:

Class II

Date Initiated: July 20, 2020

Date Posted: September 2, 2020

Recall Number: Z-2849-2020

Event ID: 86174

Reason for Recall:

Outer box labels for kit 0469247 correct, however the boxes contained the implants and jigs for 0468920

Status: Terminated

Product Quantity: 1 kit

Code Information:

Serial Number: 0469247 Exp. 2021-01-31

Distribution Pattern:

Voluntary or Mandated:

Voluntary: Firm initiated