EMPOWR 3D Knee Tibial Insert, 5R, 10MM, VE, REF: 342-10-705
Knee insert and acetabular system parts were swapped within inner pack prior to the product being sealed within the tray, which could result in surgeons not having the correct product for the surgery due to different anatomies (Hip vs Knee).
US Nationwide distribution in the states of FL, CA, IN, HI, LA, MN, AZ, TX, NJ, PA, KS, TN, PR, SC, WA.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0102-2024