Recall Z-1287-2015 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Materialise N.V.
Signature TKA GDE/MDL Set 04-05 (Femur & Tibia) The Signature Patient-Specific Surgical Guides are intended to be used as part of the Signature Personalized Patient Care System. Lt is intended to be used as a guide during the surgical procedure for total and partial knee arthroplasty.
| Date | Mar 17, 2015 (initiated Feb 4, 2015) |
| Status | Terminated |
| Reason | Images belonging to a different patient were used for the production of the patient specific surgical guide. The incorrect guide may cause a delay in surgery to accommodate the preparation and use of traditional instrumentation. |
| Root cause | Employee error |
| Action | Materialise N.V. sent an email on February 4, 2015, to the the affected distributor regarding the reason for the recall, affected product, and instructions for removing the affected product. For questions regarding this recall call 321-639-6611. |
| Quantity | 1 unit |
| Distribution | Worldwide Distribution to the Netherlands only. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102795 | SIGNATURE PLANNER; SIGNATURE GUIDES Materialise NV, Feb 2, 2011 |