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Recall Observatory FDA recall evidence

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

January 03, 2017

Class II

Product summary

Firm
Stryker Leibinger GmbH & Co. KG
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

    reason.sterility_assurance · v1.0.0

    non-sterile products labeled as sterile