Class II

Medical Device Recall: EMPOWR 3D Knee Tibial Insert, 6R 10MM, VE, REF: 342-10-706

Encore Medical, LP · December 10, 2024

Reason for Recall

Knee insert package may contain an acetabular system, which may cause surgical delay to get a new product.

Distribution

US Nationwide distribution in the states of IN, KS, CA, FL, NY, TX, AL, WA.

States Affected

NATIONWIDE

Quantity Affected

9

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0761-2025

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.