Recall Z-1433-2010 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Encore Medical, Lp
3DKNEE SYSTEM, 3D Knee Tibial Insert-DCM, Sterile, Right, size 4 x 11mm. Encore Medical, LP. Austin, TX 78758-5445. Intended to aid the surgion in relieving the patient of knee pain and restoring knee joint function.
| Date | Apr 26, 2010 (initiated Mar 19, 2010) |
| Status | Terminated |
| Reason | Affected product had incorrect color label which is a secondary visual indicator for sizing. |
| Root cause | Packaging process control |
| Action | Encore Medical, LP notified consignees by e-mail dated March 19, 2010. Consignees were requested to return the affected product to the firm. For further information, contact Encore Medical, LP at 1-888-838-3668. |
| Quantity | 7 units |
| Distribution | Worldwide Distribution -- United States (UT, IA) and Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020114 | 3D KNEE Encore Orthopedics, Inc., Jul 12, 2002 |