FDA-Device2023-10-18Class II
EMPOWR 3D Knee Tibial Insert, 5R, 10MM, VE, REF: 342-10-705
Encore Medical, LP
Hazard
Knee insert and acetabular system parts were swapped within inner pack prior to the product being sealed within the tray, which could result in surgeons not having the correct product for the surgery due to different anatomies (Hip vs Knee).
Sold states
US Nationwide distribution in the states of FL, CA, IN, HI, LA, MN, AZ, TX, NJ, PA, KS, TN, PR, SC, WA.
Affected count
36
Manufactured in
9800 Metric Blvd, N/A, Austin, TX, United States
Products
EMPOWR 3D Knee Tibial Insert, 5R, 10MM, VE, REF: 342-10-705
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0102-2024Don't want to check this manually?
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