Z-1150-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 15, 2017
- Initiation Date
- January 3, 2017
- Termination Date
- July 27, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 619
Product Description
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
Reason for Recall
An incorrect sterility status on the label, non-sterile products labeled as sterile
Distribution Pattern
Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Australia, Canada, Chile, Spain, South Africa and Taiwan.
Code Information
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