FDA-Device2026-02-11Class II
EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705
Encore Medical, LP
Hazard
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.
Sold states
US: TX, IA, MI, MS, MA, RI, NJ, PA, NY, MO, OK, PR, AL, CA
Affected count
19
Manufactured in
9800 Metric Blvd, N/A, Austin, TX, United States
Products
EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1233-2026Don't want to check this manually?
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