Disposable Paper Filter for Sterilization Containers Paper, Medical Accessory, 100 DISP, Paper F, Steri.Cases, New Shape

FDA device recall Z-0114-2016 · posted 2015-10-08 · Terminated

Recall details

Recalling firm

Stryker Craniomaxillofacial Division

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.

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

FSM

Quantity affected

915 packs

Distribution

Worldwide distribution -- US, Canada, France, Germany, Italy, Japan, Norway, Sweden, Switzerland, and the Netherlands.

Date initiated

2015-09-17

Date posted

2015-10-08

Date terminated

2016-02-26

Location

Portage, MI