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.
FDA Recall Z-0114-2016 · Posted 2015-10-08
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Recalling FirmStryker Craniomaxillofacial Division
Recall StatusTerminated
Product CodeFSM
Date Initiated2015-09-17
Date Terminated2016-02-26
Product Quantity915 packs
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.
Firm Action
An Urgent Medical Device Recall letter has been sent to the customers. The affected product was identified, as well as the reason for the recall and risk to health. The letter states that customers should inform users of the Medical Device Removal and pass the notice to all appropriate individuals within the organization; scrap all affected products available at the location or return it to Stryker Craniomaxillofacial, Attention: Recall Coordinator, at the address provided. If there are questions regarding the impacted product, don't hesitate to Contact Stryker Customer service and refer to PFA #2015-032. Complete and sign the enclosed Business Reply Form and fax or copy to: (877) 648-7114 or e-mail a copy to [email protected].
Root Cause
Device Design
Distribution Pattern
Worldwide distribution -- US, Canada, France, Germany, Italy, Japan, Norway, Sweden, Switzerland, and the Netherlands.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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