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U.S. Department of Health and Human Services

Class 2 Device Recall Disposable Paper Filter for Containers

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  Class 2 Device Recall Disposable Paper Filter for Containers see related information
Date Initiated by Firm September 17, 2015
Date Posted October 08, 2015
Recall Status1 Terminated 3 on February 26, 2016
Recall Number Z-0114-2016
Recall Event ID 72170
Product Classification Tray, surgical, instrument - Product Code FSM
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.
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)
Recalling Firm/
Manufacturer		 Stryker Craniomaxillofacial Division
750 Trade Centre Way
Ste 200
Portage MI 49002-0482
For Additional Information Contact
877-534-2464
Manufacturer 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.
FDA Determined
Cause 2		 Device Design
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 CMF-custserv@stryker.com.
Quantity in Commerce 915 packs
Distribution Worldwide distribution -- US, Canada, France, Germany, Italy, Japan, Norway, Sweden, Switzerland, and the Netherlands.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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