ConforMIS, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0658-2017)

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, Sterile Catalog Number: TCR-111-1111. Intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device.

Product Classification:

Class II

Date Initiated: October 18, 2016

Date Posted: December 7, 2016

Recall Number: Z-0658-2017

Event ID: 75553

Reason for Recall:

Mislabeled: incorrect serial number on the F4 A/P cut guide iJig.

Status: Terminated

Product Quantity: 2 units

Code Information:

Serial Numbers: 0381024; 0381042 Exp Date: 2017-02-28

Distribution Pattern:

Distributed to the states of CO and NV.

Voluntary or Mandated:

Voluntary: Firm initiated