Recall Z-2244-2010 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Encore Medical, Lp
3DKnee Baseplates, Size 8, Left, Part # 333-01-108, Lot# A1000003.
| Date | Aug 22, 2010 (initiated Jun 28, 2010) |
| Status | Terminated |
| Reason | One lot of product has an incorrect color label. The color label is a secondary visual indicator of sizing. |
| Root cause | Labeling mix-ups |
| Action | Firm notified their consignees by letter on June 28, 2010. |
| Quantity | 18 |
| Distribution | Florida, Missouri, and Italy |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020114 | 3D KNEE Encore Orthopedics, Inc., Jul 12, 2002 |