Recall Z-0581-2015 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
ConforMIS, Inc.
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.
| Date | Dec 11, 2014 (initiated Nov 19, 2014) |
| Status | Terminated |
| Reason | Incorrect serial number of tibial inserts packaged in tray may result in inserts not fitting |
| Root cause | Labeling mix-ups |
| Action | Conformis notified the consignee by telephone on 11/19/14, about the problem. A sales representative visited the site and retrieved the device. |
| Quantity | 1 unit |
| Distribution | Distributed to IN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140423 | ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM Conformis, Inc., May 27, 2014 |