Recall Z-0165-2016 ยท OIY Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
Encore Medical, Lp
Exprt Precision System: Revision Knee, Model Number 160-010-726/738 For use with the Exprt Knee System in total knee arthroplasty to replace the native patella.
| Date | Oct 26, 2015 (initiated Sep 16, 2015) |
| Status | Terminated |
| Reason | The labeling is missing the size/diameter information. |
| Root cause | Labeling design |
| Action | DJO Surgical sent an Urgent Field Safety Notice dated September 16, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter requested the consignees complete and return a response card and return affected devices for replacement. For further questions call (512) 832-6302. |
| Quantity | 209 units |
| Distribution | US Distribution to the states of : SC, WI, RI, NY, MO, AR, OK, GA, FL, AL, CA, AZ and CO. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140830 | EXPRT REVISION KNEE Encore Medical L.P., Jul 11, 2014 |