Recall Z-1064-2007 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Encore Medical, Lp
ALFA II Modular Femoral Stem Pourous Coated; Size 7; Length 200mm; Distal Diameter: 19.5mm; Catalog #651-07-195; component of the ENCORE Hip System; Single Use, Sterile; distributed by Encore Medical, L.P., Austin, TX 78758.
| Date | Jul 23, 2007 (initiated Apr 12, 2007) |
| Status | Terminated |
| Reason | Sterility/Package Integrity : Device packaging may potentially be unable to ensure sterility when exposed to shipping conditions. |
| Root cause | Other |
| Action | Urgent Device Recall Notification letters distributed to consignees on 04/14/07. Consignees requested to return product to Encore Medical, L.P. |
| Quantity | 3 units. |
| Distribution | Product distributed to surgical centers in CT, KS and MO. |
| 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 |