Recall Z-1544-2012 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Materialise USA LLC
PATIENT SPECIFIC INSTRUMENTS N-K FLEX PIN GUIDES (FEMUR AND TIBIA) NONSTERILE ~ MUST BE STERILIZED PRIOR TO USE Patient ID ..- 0864-R3 Manufactured by Materialise, Plymouth, MI Distributed by Zimmer, Warsaw IN. Patient specific instrument 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
| Date | May 14, 2012 (initiated Mar 23, 2012) |
| Status | Terminated |
| Reason | March 23, 2012 a field representative reported patient specific --0242 L tibia guide case packaging contained a different patient specific ..-0864-R tibia guide. The two patient specific products had been switched in packaging. Neither products had been delivered to the end user. |
| Root cause | Labeling mix-ups |
| Action | Materialise telephoned both field representatives on March 23, 2012 and confirmed recalled product mix-up. Materialise requested both cases be returned and replacements were provided. No affected product was received by the end user. |
| Quantity | 1 unit |
| Distribution | Nationwide Distribution including the states of Ohio and Minnesota. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111492 | ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER MODEL 2.5, ZIMMER PATIENT SPECIFIC INSTRUMENTS Materialise NV, Oct 13, 2011 |