Recall Z-1128-04 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Encore Medical, Lp
HA Hip Stem, cementless
| Date | Jul 22, 2004 (initiated Jun 30, 2004) |
| Status | Terminated |
| Reason | Hip stem product was mis-labeled with wrong size. |
| Root cause | Other |
| Action | Firm sent letter of notification to consignee on 6/30/2004. |
| Quantity | 3 units |
| Distribution | Deerfield Beach, FL |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K993943 | ENCORE LINEAR POROUS COATED HIP WITH HA, ENCORE FOUNDATION POROUS HIP WITH HA, ENCORE REVELATION POROUS HIP WITH HA Encore Orthopedics, Inc., Feb 4, 2000 |