FDA-Device2025-01-01Class II

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

Encore Medical, LP
Hazard

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

Sold states
US Nationwide distribution in the states of IN, KS, CA, FL, NY, TX, AL, WA.
Affected count
9
Manufactured in
9800 Metric Blvd, Austin, TX, United States
Products
EMPOWR 3D Knee Tibial Insert, 6R 10MM, VE, REF: 342-10-706

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0761-2025

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