Z-0114-2016 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 14, 2015
- Initiation Date
- September 17, 2015
- Termination Date
- February 26, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 915 packs
Product Description
Disposable Paper Filter for Sterilization Containers Paper, Medical Accessory, 100 DISP, Paper F, Steri.Cases, New Shape, Manufactured and distributed by Stryker Leibinger GmbH & Co KG, Distributed in the USA by: Stryker Orthopedics, NON STERILE.
Reason for Recall
Stryker has become aware that the inhomogeneity of the filter paper might potentially compromise the ability of the filter to maintain a sterile barrier during post-sterilization shelf-life.
Distribution Pattern
Worldwide distribution -- US, Canada, France, Germany, Italy, Japan, Norway, Sweden, Switzerland, and the Netherlands.
Code Information
Part Number: 29-10911 Disposable Paper Filter for Sterilization Container, 30x29cm, new type (P/100); 29-10912 Disposable Paper Filter for Sterilization Container, 60x 29cm, old type (P/100), obsolete (Part not distributed in the US); 29-10913 Dispoable Paper Filter for Sterilization Container, 60x29cm new type (P/100) (Part not distributed in the US); 29-10915 Disposable Paper Filter, 4-holes, for Coiner (Part not distributed in the US)