Conformis, Inc.: Medical Device Recall in 2019 - (Recall #: Z-1079-2019)

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 Posterior Stabilized (PS) Knee Replacement System, Catalog Number TPS-111-1111 - 020102

Product Classification:

Class II

Date Initiated: January 4, 2019

Date Posted: April 10, 2019

Recall Number: Z-1079-2019

Event ID: 82101

Reason for Recall:

The labeling of the boxes and sterile pouches did not match the contents.

Status: Terminated

Product Quantity: 2

Code Information:

Serial Numbers 0434436 and 0434836

Distribution Pattern:

The products were distributed to the following US states: NH. The products were distributed to the following foreign countries: Germany

Voluntary or Mandated:

Voluntary: Firm initiated