Device product
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.
Z-0114-2016
Product summary
- Event
- Event 72170
- Status
- Terminated
- Classification
- Class II
- Quantity
- 915 packs
- Official record key
device-enforcement:Z-0114-2016
Official wording
Reason: 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.
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)
Distribution pattern: Worldwide distribution -- US, Canada, France, Germany, Italy, Japan, Norway, Sweden, Switzerland, and the Netherlands.
Derived failure modes
-
Unknown
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.