FDAFDA · Food and drugs·Recall number Z-1150-2017
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
Published February 15, 2017 · Recall initiated: January 3, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
An incorrect sterility status on the label, non-sterile products labeled as sterile
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Stryker Leibinger GmbH & Co. KG
- Distributor
- Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Australia, Canada, Chile, Spain, South Africa and Taiwan.
- Lot
- 9805 Orbital Volume Sizer Set with Tray (Non-sterile) Lot M1311023 9951 Design M Malar Sizer Set (Silicone, Non-Sterile) Lot M1305001 9952 Extended Contoured, Malar Sizer Set (Silicone, Non-Sterile) Lot M1603004 85000 Petite Nasal Dorsum Sizer Set (Silicone, Non-Sterile) Lot M1603003
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Germany
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