Recall Z-0014-2011 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Stryker Howmedica Osteonics Corp.
Duracon Total Knee Distal Femoral Locking Screw for 5 mm Spacer; Product No. 6632-5-600. Made in Ireland; Howmedica Osteonics; 325 Corporate Drive, Mahwah, NJ 07430 Intended for primary or secondary reconstruction of the distal femur.
| Date | Oct 6, 2010 (initiated Oct 5, 2006) |
| Status | Terminated |
| Reason | Stryker Orthopaedics became aware that a box labeled as Duracon Total Knee Distal Femoral Locking Screws for 5 mm spacer, may actually contain a 10 mm screw. |
| Root cause | Labeling mix-ups |
| Action | Important Market Withdrawal Letters were sent via Federal Express October 5, 2006. The letters identified the affected product and the reason for recall. Customers were asked to examine their inventory to identify the product; and retrieve all affected product lots and return it their branch or agency warehouse for reconciliation. All product should be reconciled on the Product Accountability Form and the form should be faxed back. Customers are to contact a Customer Service Rep to re-order the product that is being returned. Questions can be directed to Rita Intorrella on 201-831-5825. |
| Quantity | 7 units |
| Distribution | Nationwide Distribution -- Including Ohio. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K920034 | DURACON MODULAR FEMORAL COMPONENT AND FEMORAL SPAC Pfizer Hospital Products Group, Inc., Mar 18, 1992 |