FDA-Device2025-01-01Class II
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
Hazard
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.
Sold states
US Nationwide distribution in the states of VA, MN, TX, WI, IA, IL, IN, SC, NY, MD, CA, FL, AZ, WA.
Affected count
33
Manufactured in
9800 Metric Blvd, Austin, TX, United States
Products
EMPOWR 3D Knee Tibial Insert, 5R 16MM, VE, REF: 342-16-705; EMPOWR 3D Knee Tibial Insert, 3R 14MM, VE, REF: 342-14-703
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0766-2025Don't want to check this manually?
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