Recall Z-0145-2016 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
ConforMIS, Inc.
ConForMIS iTotal CR (Cruciate Retaining) Knee Replacement System-iTOTAL CR, Left Knee Catalog Number: M57250600010 (US) M5725INT0600010 (OUS)
| Date | Oct 21, 2015 (initiated Aug 31, 2015) |
| Status | Terminated |
| Reason | May contain small amounts of ethylene glycol residue |
| Root cause | Process design |
| Action | ConForMIS issued a Press on August 31, 2015 to the general public The sales force was notified through email. The sales personnel for affected accounts that had upcoming surgeries scheduled were asked to confirm that the affected surgeries were cancelled and that the devices were not used in surgery (Formal notification letters will be distributed to the affected accounts by Tuesday, September 8, 2015. The user required to confirm their understanding of the recall and to return any unused product to ConforMIS. Distribution of the letters conducted in two phases as described below: Phase 1-Surg |
| Quantity | 313 units |
| Distribution | Distributed Nationwide and in Germany, Switzerland, and UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142161 | ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM, ITOTAL POSTERIOR STABILIZED (PS) KNEE REPLACEMENT SYSTEM Conformis, Inc., Nov 14, 2014 |