FDA-Device2022-06-15Class II
DJO EMPOWR 3D Knee (Right) 10mm Tibial Insert, REF: 342-10-708
Encore Medical, LP
Hazard
A right, size 8, knee tibial insert package may include a mispackaged, left ,size 4, knee tibial insert. If implanted, a risk may include leaving debris in the joint space.
Sold states
U.S. Nationwide distribution in the states of TN, MN, IL, IN, SC, MS, CA, KS.
Affected count
20
Manufactured in
9800 Metric Blvd, Austin, TX, United States
Products
DJO EMPOWR 3D Knee (Right) 10mm Tibial Insert, REF: 342-10-708
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1257-2022Don't want to check this manually?
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