ConforMIS, Inc.: Medical Device Recall in 2014 - (Recall #: Z-0581-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

Conformis iTotal CR G2 Knee Replacement System Catalog/Model #: M57250600010 Intended for use as a total knee replacement in patients with knee joint pain and disability.

Product Classification:

Class II

Date Initiated: November 19, 2014

Date Posted: December 17, 2014

Recall Number: Z-0581-2015

Event ID: 69867

Reason for Recall:

Incorrect serial number of tibial inserts packaged in tray may result in inserts not fitting

Status: Terminated

Product Quantity: 1 unit

Code Information:

Serial Number: 0340552

Distribution Pattern:

Distributed to IN.

Voluntary or Mandated:

Voluntary: Firm initiated