Recall Z-1941-2016 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Materialise USA LLC
Signature TKA GDE/MDL Set 04-05 Patient-specific surgical guide and instrument set.
| Date | May 3, 2016 |
| Status | Terminated |
| Reason | A patient specific case of Signature Personalized Patient Care System Knee Guides included a femur guide which does not match the patient associated with the case. If the issue is not identified prior to surgery, the personalized patient specific guide would provide an improper fit and would not be able to be used. |
| Root cause | Process control |
| Action | Materialise sent an URGENT: Signature Personalized Patient Care System Knee Guides Notification dated May 3, 2016. It was sent to the affected customer via email with instructions for identifying and returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Contact Materialise customer service for additional information or to find a status of the second patient specific surgical guide Monday through Friday, 8:00AM to 4:30 PM, Ea |
| Quantity | 1 |
| Distribution | One consignee, Indiana. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102795 | SIGNATURE PLANNER; SIGNATURE GUIDES Materialise NV, Feb 2, 2011 |