9805 Orbital Volume Sizer Set with Tray (Non-sterile) 9951 Design M Malar Sizer Set (Silicone, Non-Sterile) 9952 Extended Contoured,...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1150-2017.
An incorrect sterility status on the label, non-sterile products labeled as sterile
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1150-2017.
Recall terminated by FDA.
✅ What you should do
- Stop using the product if you own it.
- Check the model number, lot code, or sell-by date against the recall notice above.
- Contact Stryker Leibinger Gmbh & Co. Kg or the retailer where you bought it for a refund, replacement, or repair.
- For the most current official instructions, visit the FDA recall page.
- If you've been hurt by this product, report the incident to FDA.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1150-2017.
Stryker Leibinger GmbH & Co. KG
About the U.S. Food and Drug Administration
The FDA regulates drugs, medical devices, food, cosmetics, and tobacco. Adverse event reports and recall notices are the main public safety signal.
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If you had a reaction, found contamination, or experienced a labeling problem with this product, report it to the FDA. The agency uses consumer reports to track emerging safety signals and trigger recalls.
Stryker Leibinger Gmbh & Co. Kg Recall FAQ
Stryker Leibinger Gmbh & Co. Kg is the subject of a medical implants safety report: 9805 Orbital Volume Sizer Set with Tray (Non-sterile) 9951 Design M Malar Sizer Set (Silicone, Non-Sterile) 9952 Extended Contoured,.... The notice was published on January 3, 2017 by the U.S. Food and Drug Administration (FDA). Approximately 619 units are potentially affected.