Recall Z-0331-06 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Encore Medical, Lp
Size 6 right Foundation Total Knee System (Catalog #324-01-106) knee joint replacement.
| Date | Dec 29, 2005 (initiated Nov 3, 2005) |
| Status | Terminated |
| Reason | The product is mislabeled in that Size 6 right Foundation may contain size 8 right 3D knee non-porous baseplates and vice versa. Device is intended to aid surgeon in relieving knee pain and restoring knee joint function. |
| Root cause | Other |
| Action | Firm initiated recall on 11/03/05 via letter to all consignees. |
| Quantity | 16 units. |
| Distribution | Device distributed to direct accounts in AZ, CA, FL, GA, MO, NJ, OK, SC, SD and TX. Foreign consignies located in Freiburg and Langelsheim, Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K923277 | FOUNDATION KNEE SYSTEM Encore Orthopedics, Inc., Feb 9, 1993 |