FDA-Device2026-03-04Class II
Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 7L 16MM, VE Model/Catalog Number: 341-16-707
Encore Medical, LP
Hazard
Knee and Humeral socket implants contain incorrect labeling.
Sold states
US Nationwide distribution in the states of VA, TN, IL, IN, MI, CO, WY, MT, RI, MA, NJ, PA, MO, OK, LA, FL, CA.
Affected count
14 implants
Manufactured in
9800 Metric Blvd, N/A, Austin, TX, United States
Products
Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 7L 16MM, VE Model/Catalog Number: 341-16-707
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1459-2026Original summary
Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 7L 16MM, VE Model/Catalog Number: 341-16-707 Knee and Humeral socket implants contain incorrect labeling. Lot Code: Lot: 151T1055A GTIN: 00888912167147 Distribution: US Nationwide distribution in the states of VA, TN, IL, IN, MI, CO, WY, MT, RI, MA, NJ, PA, MO, OK, LA, FL, CA. Affected quantity: 14 implants
Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief