Recall Z-0418-2015 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Materialise USA LLC
Zimmer Patient Specific Instrument PERSONA CR Pin Guides (Femur and Tibia) is intended to be used as a surgical instrument to assist in the positioning of Total Knee Replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.
| Date | Nov 21, 2014 (initiated Oct 16, 2014) |
| Status | Terminated |
| Reason | The box of guides for a specific case arrived intact but contained two (2) femoral guides instead of one (1) femoral guide and one (1) tibial guide. The device did not meet specification: One tibia guide missing and one femur guide contained an edge which was +0.04 mm over specification. |
| Root cause | Nonconforming Material/Component |
| Action | Materialise USA was notified on October 16, 2014 by the Field Representative of the distributor (Zimmer) that the box of guides for case JTOMA-JL-0636-L arrived intact but contained two (2) femoral guides instead of one (1) femoral guide and one (1) tibial guide. A new set of tibial and femoral guides were manufactured and sent to Zimmer (headquarters distribution center) on October 17, 2014 before the surgery date on October 20, 2014. For questions regarding this recall call 734-662-5057. |
| Quantity | 1 |
| Distribution | Nationwide Distribution to MN only |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121640 | ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM Materialise NV, Dec 5, 2012 |