Class II
Medical Device Recall: EMPOWR 3D Knee Tibial Insert, 5R 16MM, VE, REF: 342-16-705; EMPOWR 3D Knee Tibial Insert, 3R 14MM, VE, REF: 342-14-703
Encore Medical, LP · December 18, 2024
Reason for Recall
5R 16MM knee tibial insert package may contain knee tibial insert 3R 14MM and vice versa, which may cause surgical delay to get a new product.
Distribution
US Nationwide distribution in the states of VA, MN, TX, WI, IA, IL, IN, SC, NY, MD, CA, FL, AZ, WA.
States Affected
NATIONWIDE
Quantity Affected
33
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0766-2025
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.