Z-0114-2016Class II

Disposable Paper Filter for Sterilization Containers Paper, Medical Accessory, 100 DISP, Paper F...

Name: Z-0114-2016 Disposable Paper Filter for Sterilization Containers Paper, Medical Accessory, 100 DISP, Paper F...
Creator: Stryker Craniomaxillofacial Division
Published: 2015-09-17
License: https://open.fda.gov/license/

Stryker Craniomaxillofacial Division / initiated 2015-09-17 / Terminated / root cause: design

FDA source

Stryker Craniomaxillofacial Division began a recall of Disposable Paper Filter for Sterilization Containers Paper, Medical Accessory, 100 DISP, Paper F, Steri.Cases, New Shape, Manufactured and distributed by... on 2015-09-17. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0114-2016
Classification: Class II
Status: Terminated
Initiated: 2015-09-17
Posted: 2015-10-08
Terminated: 2016-02-26
Recalling firm: Stryker Craniomaxillofacial Division
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.
Product code: FSM Tray, Surgical, Instrument
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.
Root cause tag: design
FDA root cause: 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 [email protected].
Quantity in commerce: 915 packs
Distribution: Worldwide distribution -- US, Canada, France, Germany, Italy, Japan, Norway, Sweden, Switzerland, and the Netherlands.
Product codes and lots: 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)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0114-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0114-2016	Class II	Terminated	Voluntary: Firm initiated	2015-10-14	2015-10-08

Product code FSM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)