Recall Z-1539-2008 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Encore Medical, Lp
3DKNEE Tibial Insert Trial, Size 2, 13mm Right; Part #801-01-640; manufactured by Encore Medical, L.P., Austin, TX 78758. Used in surgery to determine the correct size of 3DKnee component to implant that would allow for the best range of motion and joint stability.
| Date | Aug 20, 2008 (initiated Feb 20, 2008) |
| Status | Terminated |
| Reason | Tibial insert trial incorrectly marked for thickness; device thickness marked correctly as 13mm on the underside of the trial, but is incorrectly marked as 15mm on the side. |
| Root cause | Error in labeling |
| Action | Firm notified consignee by phone and asked them to return any outstanding product on 02/20/08. |
| Quantity | 6 units. |
| Distribution | Distribution --- country of Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020114 | 3D KNEE Encore Orthopedics, Inc., Jul 12, 2002 |