Class II

Medical Device Recall: EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705

Encore Medical, LP · January 5, 2026

Reason for Recall

942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cause surgical delay to exchange devices or revision surgery.

Distribution

US: TX, IA, MI, MS, MA, RI, NJ, PA, NY, MO, OK, PR, AL, CA

States Affected

AL, CA, IA, MA, MI, MO, MS, NJ, NY, OK, PA, RI, TX

Quantity Affected

19

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1233-2026

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.