Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

9805 Orbital Volume Sizer Set with Tray (Non-sterile) 9951 Design Recalled by Stryker Leibinger GmbH & Co. KG Due to An incorrect sterility status on the label, non-sterile...

Date: January 3, 2017
Company: Stryker Leibinger GmbH & Co. KG
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Stryker Leibinger GmbH & Co. KG directly.

Affected Products

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

Quantity: 619

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Stryker Leibinger GmbH & Co. KG

Stryker Leibinger GmbH & Co. KG has 25 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report