FDASeptember 17, 2015device

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.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

stryker craniomaxillofacial divisionstrykerstryker craniomaxillofacial

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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