Recall Z-2222-2012 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Conformis Inc
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 tr
| Date | Aug 17, 2012 (initiated Jul 17, 2012) |
| Status | Terminated |
| Reason | Addendum Labeling iTotal CR Surgical Technique with Detailed Instructions of Total CR Poly Insertion Technique |
| Root 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 proce |
| Quantity | 1427 units |
| Distribution | Worldwide Distribution - US Nationwide and the country of Germany |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103117 | ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM Conformis, Inc., Jan 7, 2011 |