Encore Medical, LP Recall 92969
Description: DJO Surgical: Empowr Knee, Universal Tibia Baseplate, 6R, REF: 352-02-106
Encore Medical, LP Recall 92969 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2603-2023 |
| Event ID | 92969 |
| Event Description | DJO Surgical: Empowr Knee, Universal Tibia Baseplate, 6R, REF: 352-02-106 |
| Product Type | Devices |
| Distribution | US: AL, AZ, CA, CO, FL, IL, IN, KS, KY, LA, MA, MI, MN, MO, NC, NJ, NY, OH, PA, PR, RI, SC, TX, UT, VA, WA. OUS: Sweden, Australia, France, UK, Colombia, Germany |
| Quantity | 20 |
| Recall Reason | Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, which may require treatment, prolonged monitoring, and may lead to revision surgery |
| Device Classification | 20230927 |
| Device Code Info | UDI-DI/Lot/Expiration: 00190446258032/308V1112/May 25, 2029 |
| Center Classification Date | 20230919 |
| Recall Initiation Date | 20230804 |
| Recalling Firm | Encore Medical, LP |
| Initial Notification | Letter |
| Similar To |