Recall Z-1150-2017— Stryker Leibinger GmbH & Co. KG
Class II · Terminated
Class II FDA medical device recall by Stryker Leibinger GmbH & Co. KG, initiated 2017-01-03, terminated 2017-07-27. It names one FDA 510(k) clearance: K833586. 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. Reason: An incorrect sterility status on the label, non-sterile products labeled as sterile.
- Recalling firm
- Stryker Leibinger GmbH & Co. KG
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-01-03
- Terminated
- 2017-07-27
- Firm location
- Freiburg, N/A, Germany
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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
Reason for recall
An incorrect sterility status on the label, non-sterile products labeled as sterile
Data sourced from openFDA. This site is unofficial and independent of the FDA.