Conformis Inc: Medical Device Recall in 2012 - (Recall #: Z-2222-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

Conformis iTotal CR-Cruciate Retaining Knee Replacement System Model Numbers: M57250600010 iTotal CR, Left Knee M57250600020 iTotal CR, Right Knee Product Usage : Usage: The iTotal CR Knee Replacement System (KRS) is 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 that treats only one or two of the three knee compartments, such as a unicondylar, patello-femoral or bi-compartmental prosthesis.

Product Classification:

Class II

Date Initiated: July 17, 2012

Date Posted: August 29, 2012

Recall Number: Z-2222-2012

Event ID: 62576

Reason for Recall:

Addendum Labeling iTotal CR Surgical Technique with Detailed Instructions of Total CR Poly Insertion Technique

Status: Terminated

Product Quantity: 1427 units

Code Information:

All serial numbers

Distribution Pattern:

Worldwide Distribution - US Nationwide and the country of Germany

Voluntary or Mandated:

Voluntary: Firm initiated