Agency classClass IIOur severity:High FDA (Devices)·Z-0114-2016·Announced 2015-10-14

Stryker Recalls Disposable Paper Filters for Sterilization Containers

Stryker is recalling disposable paper filters for sterilization containers because inhomogeneous paper may compromise the sterile barrier during shelf-life.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a potential failure of a sterile barrier, which is a high-risk hazard for medical devices, but the source text does not report any illnesses or injuries, placing it in the 'High' category per the rubric for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Stryker Craniomaxillofacial Division is recalling 915 packs of Disposable Paper Filters for Sterilization Containers. The affected products are part numbers 29-10911, 29-10912, 29-10913, and 29-10915. These filters are non-sterile medical accessories used in sterilization containers.

The recall was initiated because Stryker became aware that the inhomogeneity of the filter paper might potentially compromise the filter's ability to maintain a sterile barrier during post-sterilization shelf-life. This defect could potentially affect the sterility of items stored in the containers.

The products were distributed worldwide, including in the US, Canada, France, Germany, Italy, Japan, Norway, Sweden, Switzerland, and the Netherlands. In the US, they were distributed by Stryker Orthopedics. Users should stop using the affected filters and contact Stryker for instructions on return or replacement.

The recalled product

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.
Manufacturer: Stryker Craniomaxillofacial Division
Category: Medical Device — Sterilization Accessories
Hazard: sterility-compromise
Affected units: 915

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (12)

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)

Distribution

Distribution scope not specified by the agency.

Same manufacturer · Stryker Craniomaxillofacial Division

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Same hazard · sterility compromise