Recall Z-1011-04 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Encore Medical, LP
3DKnee System, Stemmed Tibia-Nonporous-3D, Size 6, Right, sterile. Manufactured by Encore Orthopeadics, 9800 Metric Blvd., Austin, Texas 78758
| Date | Jul 20, 2004 (initiated May 10, 2004) |
| Status | Terminated |
| Reason | Labeling is switched for the two products recalled. 3DKNEE is labeled as Foundation and Foundation is labeled as 3DKNEE |
| Root cause | Other |
| Action | The firm sent recall letters to all consignees on May 10, 2004 requesting return of the product. |
| Quantity | 16 |
| Distribution | Product was distributed domesically to the following states: IA, MA, OK, TX, FL, CA, and SD. Product was shipped to one distributor in Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020114 | 3D KNEE Encore Orthopedics, Inc., Jul 12, 2002 |