Class 2 Device Recall Conformis

• Date Initiated by Firm: July 17, 2012
• Date Posted: August 17, 2012
• Recall Status: Terminated on February 27, 2013
• Recall Number: Z-2222-2012
• Recall Event ID: 62576
• 510(K)Number: K103117
• Product Classification: Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
• Product: 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.
• Code Information: All serial numbers
• Recalling Firm/ Manufacturer: Conformis Inc; 1 North Ave; Suite B; Burlington MA 01803-3305
• Manufacturer Reason for Recall: Addendum Labeling iTotal CR Surgical Technique with Detailed Instructions of Total CR Poly Insertion Technique
• FDA Determined Cause: Device Design
• Action: ConforMIS sent an Urgent Field Safety Notice letter dated July 5, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. An Addendum is included that provided updates to the Surgical Technique Guide. The updated technique guide will be delivered to all iTotal surgeons along with an on-site vist from ConforMIS sales representative. Customers were instructed to place the Surgical Technique Guide Addendum alongside the surgical plan, it puts the information in a highly visible location for the surgeon to review prior to the surgical procedure. Customers were asked to sign the communication verification form attached. For any questions regarding this notice, please contact your local ConforMIS representative or MDSS GmbH, Tel.: +49-511-62628630, info@mdss.com.
• Quantity in Commerce: 1427 units
• Distribution: Worldwide Distribution - US Nationwide and the country of Germany
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = JWH