Reported Feb 15, 2017 · Terminated
9805 Orbital Volume Sizer Set with Tray (Non-sterile) 9951 Design M Malar Sizer Set (Silicone, Non-Sterile) 9952…
Stryker Leibinger GmbH & Co. KG
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Stryker Leibinger GmbH & Co. KG · Botzinger Strasse 41 · Freiburg, N/A · N/A
Is this the product you have?
- 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
- Lot codes and dates
4 of 4 products
Products covered by this recall # Product as published 1 Lot M1311023 9951 Design M Malar Sizer Set (Silicone, Non-Sterile) 2 Lot M1305001 9952 Extended Contoured, Malar Sizer Set (Silicone, Non-Sterile) 3 Lot M1603004 85000 Petite Nasal Dorsum Sizer Set (Silicone, Non-Sterile) 4 Lot M1603003 - Amount recalled
- 619
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
An incorrect sterility status on the label, non-sterile products labeled as sterile
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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