Device 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
Z-1150-2017
Product summary
- Event
- Event 76146
- Status
- Terminated
- Classification
- Class II
- Quantity
- 619
- Official record key
device-enforcement:Z-1150-2017
Official wording
Reason: An incorrect sterility status on the label, non-sterile products labeled as sterile
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
Distribution pattern: Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Australia, Canada, Chile, Spain, South Africa and Taiwan.
Derived failure modes
-
Sterility assurance
non-sterile products labeled as sterile