Recall Z-1601-2009 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Stryker Howmedica Osteonics Corp.
Duracon Total Knee, A-P Lipped Tibial Insert; 11MM Sterile; Howmedica Osteonics Corp. Stryker, Ireland. Product No. 6642-1-611. The device is used to replace bearing surface if the proximal tibia in order to relieve pain, instability and/or restriction of motion due to degenerative joint disease, failed previous prosthesis or trauma. The tibial inserts are designed to accommodate the posterior c
| Date | Jul 7, 2009 (initiated May 5, 2006) |
| Status | Terminated |
| Reason | A box packaged and labeled as a Duracon Total Knee Duration A-P Lipped Tibial Insert 11MM may actually contain a 9MM insert. |
| Root cause | Labeling mix-ups |
| Action | A notification letter and product accountability form were sent via Federal Express on May 5, 2006 with return receipt to branch accounts that had received the affected product. For questions about the recall contact Stryker Howmedica Osteonics Corp. by calling 1-201-831-5000. |
| Quantity | 8 |
| Distribution | Nationwide Distribution (AL, OH, MN, NM, and CA). |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K915512 | DURACON TOTAL KNEE SYSTEM TIBIAL COMPONENTS Pfizer Hospital Products Group, Inc., Aug 18, 1992 |