Stryker Leibinger GmbH & Co. KG product recalled over sterility concerns

Recall date

January 3, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

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 Extend…

Recall number

Z-1150-2017

FDA classification

Class II

Brand / firm

Stryker Leibinger GmbH & Co. KG

Sold / distributed

Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Australia, Canada, Chile, Spain, South Africa and Taiwan.

Why it was recalled

An incorrect sterility status on the label, non-sterile products labeled as sterile

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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