Stryker Leibinger GmbH & Co. KG: Medical Device Recall in 2017 - (Recall #: Z-1150-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: January 3, 2017

Date Posted: February 15, 2017

Recall Number: Z-1150-2017

Event ID: 76146

Reason for Recall:

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

Status: Terminated

Product Quantity: 619

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.

Voluntary or Mandated:

Voluntary: Firm initiated