Recall Z-1213-2013 ยท OIY Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
Encore Medical, Lp
3DKnee e+ Tibial Insert. The insert is used along with the other components that comprise the 3DKnee System.
| Date | May 2, 2013 (initiated Apr 1, 2013) |
| Status | Terminated |
| Reason | U.S. Agent contacted Director Commercial Logistics, notifying him of incorrect color coded labels on two packages of e+tibial inserts. There were 8 e+ tibial inserts of the same lot number in Finished Goods as the two from the agency. These devices were inspected and all were incorrectly labeled. |
| Root cause | Labeling mix-ups |
| Action | The firm sent their US customer a "Urgent Field Safety Notice" letter on April 1, 2013. The letter explained the product problem and provided recommended actions as well as customer contact numbers. |
| Quantity | 5 |
| Distribution | US Distribution to the state of California and International Distribution to the country of Venezuela. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K091956 | HIGHLY CROSS-LINKED VITAMIN E UHMWPE TIBIAL INSERTS, MODEL 391/392-09_19-702_712 Encore Medical L.P., Sep 28, 2010 |