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Stryker Leibinger GmbH & Co. KG recalls 9805 Orbital Volume Sizer Set with Tray (Non-sterile) 9951 Design M Malar Sizer Set (Silicone, Non-Sterile) 9952 Ex
Recalled February 15, 2017 · FDA recall Z-1150-2017 · Stryker Leibinger GmbH & Co. KG
Hazard
An incorrect sterility status on the label, non-sterile products labeled as sterile · FDA Class II
Units
619
Sold at
Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Australia, Canada, Chile, Spain, South Africa and Taiwan.
Description
An incorrect sterility status on the label, non-sterile products labeled as sterile
Product
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
Manufacturer(s)
Stryker Leibinger GmbH & Co. KG
Made in
Germany
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →