CLASS II Device recall · Reported 14 Oct 2015 · FDA Enforcement Report

Disposable Paper, Medical Accessory, 100 DISP, Paper F recalled

Stryker Craniomaxillofacial Division is recalling Disposable Paper, Medical Accessory, 100 DISP, Paper F, Steri.Cases, New Shape. The recall was initiated on 17 Sep 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPart 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)

Quantity recalled915 packs

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0114-2016
FDA event ID: 72170
Recalling firm: Stryker Craniomaxillofacial Division, Portage, MI
Classification: Class II
Status: Terminated
Recall initiated: 17 Sep 2015
FDA classified: 8 Oct 2015
Reported: 14 Oct 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Hip & Knee Implants

Timeline

17 Sep 2015	Recall initiated by company
8 Oct 2015	Classified by FDA	+21 days
14 Oct 2015	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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.

Where it was distributed

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

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

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)

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Stryker Craniomaxillofacial Division

All 6

Reported	Class	Recall	Company	Reason	Where
18 Feb 2015Device	CLASS II	Medpor Titan Max Orbital Floor and Wall recalled	Stryker Craniomaxillofacial Division	Other	Nationwide
18 Feb 2015Device	CLASS II	Medpor Surgical Implant Contoured Two Piece Chin recalled	Stryker Craniomaxillofacial Division	Device Malfunction	Nationwide
18 Feb 2015Device	CLASS II	Medpor Barrier Sheets Orbital Floor Implant recalled	Stryker Craniomaxillofacial Division	Potency & Assay	Nationwide
18 Feb 2015Device	CLASS II	Medpor Barrier Sheets Rectangle recalled by Stryker Craniomaxillofacial	Stryker Craniomaxillofacial Division	Potency & Assay	Nationwide
4 Sep 2013Device	CLASS II	Stryker Part Numbers 79-43903 (3cc), 79-43905 (5cc) recalled	Stryker Craniomaxillofacial Division	Packaging Defects	Nationwide

Other Hip & Knee Implants recalls

All 3,097

Reported	Class	Recall	Company	Reason	Where
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled	Medline Industries	Other	Nationwide
26 Aug 2026Device	CLASS II	Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation	Kico Knee Innovation	Device Malfunction	19 states
26 Aug 2026Device	CLASS II	Veritas Standard Reverse Total Shoulder Veritas Standard recalled	restor3d	Device Malfunction	Nationwide
19 Aug 2026Device	CLASS II	Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled	Waldemar Link GmbH & Co. KG (Mfg Site)	Other	IN
12 Aug 2026Device	CLASS II	U2 Total Knee System Femoral offset bushing recalled	United Orthopedic	Device Malfunction	Nationwide