The Recall Desk

FDA (Devices) recall action 76146

Stryker Leibinger GmbH & Co. KG recalled 2 products on 2017-02-15

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2017-02-15
Critical
0
Units
1,238

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • ModerateFDA (Devices)··2017-02-15

    Stryker Leibinger Recalls Non-Sterile Medpor Implant Sizer Sets Due to Labeling Error

    Stryker Leibinger is recalling specific non-sterile Medpor implant sizer sets because they were incorrectly labeled as sterile. The recall covers 619 units distributed in the US and several international countries.

    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
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2017-02-15

    Stryker Leibinger Recalls Surgical Drainage Accessories Due to Sterility Labeling Error

    Stryker Leibinger is recalling QUINTUBE Monitor Packs and SPG Bulb Drain Systems because non-sterile products were incorrectly labeled as sterile.

    Product
    QUINTUBE Monitor Pack (5 tubes/pk, 24 pk/case) (Non-Sterile) SPG Bulb Drain System, 4mm Flat w/Center Holes (Sterile) Accessories to TLS Surgical Drainage System
    Category
    Distribution
    0 states