FDA-Device2021-07-28Class II
DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-16-711 Left Sz. 11 16mm, CE 0086, Sterile H2O2, UDI: (01)00888912167185
Encore Medical, LP
Hazard
Packaging mixup; There is a potential that packaging identified as 12mm knee prosthesis contains 16mm knee prosthesis and 16mm knee prosthesis packaging contains 12 mm knee prosthesis.
Sold states
US: Nationwide Distribution in the states of VA, MN, TX, IL, MS, CA, KS, LA, and GA OUS: None
Affected count
10 units
Manufactured in
9800 Metric Blvd, N/A, Austin, TX, United States
Products
DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-16-711 Left Sz. 11 16mm, CE 0086, Sterile H2O2, UDI: (01)00888912167185
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2104-2021Don't want to check this manually?
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