ConforMIS, Inc.: Medical Device Recall in 2016 - (Recall #: Z-1070-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Conformis iTotal Cruciate Retaining (CR) Knee Replacement System Model: TCR-111-1111

Product Classification:

Class II

Date Initiated: January 28, 2016

Date Posted: March 16, 2016

Recall Number: Z-1070-2016

Event ID: 73246

Reason for Recall:

Incorrect femoral component distributed

Status: Terminated

Product Quantity: 1 unit

Code Information:

Serial Number:0363410 UDI - M572TCR1111111021/$$316073103634108

Distribution Pattern:

Voluntary or Mandated:

Voluntary: Firm initiated