Recall Z-1868-2008 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Encore Medical, Lp
Encore Modular Femoral Neck, 12 degree/35 mm; Ref #410-35-112; distributed by Encore Medical, Austin, TX 78758. Designed to ensure the proper anteversion and femoral head orientation in the acetabulum.
| Date | Aug 26, 2008 (initiated May 8, 2008) |
| Status | Terminated |
| Reason | Product not manufactured to specifications; modular femoral necks found to contain 24 scallops, instead of the standard 12. |
| Root cause | Nonconforming Material/Component |
| Action | Firm notified sales agents of recall on 05/08/08 via an Urgent: Medical Device Recall letter. Sales agents asked to immediately examine their inventory and quarantine product subject to recall. Agents are asked to notify their customers if they had further distributed the product. All product must be returned to Encore along with the response form. |
| Quantity | 20 units |
| Distribution | Worldwide Distribution --- USA including states of IN, KS, GA, WA, SD, and countries of Greece and Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K000817 | OMEGA II MODULAR TOTAL HIP SYSTEM Osteoimplant Technology, Inc., Jun 8, 2000 |