Recall Z-0114-2016— Stryker Craniomaxillofacial Division
Class II · Terminated
Class II FDA medical device recall by Stryker Craniomaxillofacial Division, initiated 2015-09-17, terminated 2016-02-26. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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..
- Recalling firm
- Stryker Craniomaxillofacial Division
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-09-17
- Terminated
- 2016-02-26
- Firm location
- Portage, MI, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.