Events

Recall of Disposable Paper Filter for Containers

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stryker Craniomaxillofacial Division.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    72170
  • Event Risk Class
    Class 2
  • Event Number
    Z-0114-2016
  • Event Initiated Date
    2015-09-17
  • Event Date Posted
    2015-10-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-02-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140151
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Tray, surgical, instrument - Product Code FSM
  • 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.
  • 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.

Device

Disposable Paper Filter for Containers
  • Model / Serial
    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)
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution -- US, Canada, France, Germany, Italy, Japan, Norway, Sweden, Switzerland, and the Netherlands.
  • 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.
  • Manufacturer
    Stryker Craniomaxillofacial Division

Manufacturer

Stryker Craniomaxillofacial Division
  • Manufacturer Address
    Stryker Craniomaxillofacial Division, 750 Trade Centre Way, Ste 200, Portage MI 49002-0482
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA