Recall Z-0600-2018 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
ConforMIS, Inc.
Total Knee Replacement , Catalog/Model # TPS-111-1111, UDI: +M572TPS1111111021/$$+31712310398482- and +M572TPS1111111021/$$+31712310399917/ 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, patel
| Date | Jul 24, 2017 |
| Status | Terminated |
| Reason | Implant kit mislabeled |
| Root cause | Employee error |
| Action | On July 10, 2017, ConforMIS notified their Sales Representatives about a possible product mislabeling. On July 11, 2017, ConforMIS secured impacted product. On July 21, 2017, ConforMIS issued a Memorandum to their Sales Representatives. ConforMIS requested that the kits be returned to ConforMIS for investigation and disposition. For further questions, please call (781) 345-9001. |
| Quantity | 2 units |
| Distribution | US Distribution to the states of :CA and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K161668 | ConforMIS iTotal(R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS) Conformis, Inc., Jul 15, 2016 |