FDA-Device2017-02-15Class II
9805 Orbital Volume Sizer Set with Tray (Non-sterile) 9951 Design M Malar Sizer Set (Silicone, Non-Sterile) 9952 Extended Contoured, Malar Sizer Set (Silicone, Non-Sterile) 85000 Petite Nasal Dorsum Sizer Set (Silicone, Non-Sterile) Accessories to Medpor Implants
Stryker Leibinger GmbH & Co. KG
Hazard
An incorrect sterility status on the label, non-sterile products labeled as sterile
Sold states
Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Australia, Canada, Chile, Spain, South Africa and Taiwan.
Affected count
619
Manufactured in
Botzinger Strasse 41, N/A, Freiburg, N/A, Germany
Products
9805 Orbital Volume Sizer Set with Tray (Non-sterile) 9951 Design M Malar Sizer Set (Silicone, Non-Sterile) 9952 Extended Contoured, Malar Sizer Set (Silicone, Non-Sterile) 85000 Petite Nasal Dorsum Sizer Set (Silicone, Non-Sterile) Accessories to Medpor Implants
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1150-2017Don't want to check this manually?
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