Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0114-2016 — 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.

U.S. FDA — Device Enforcement · United States · 2015-09-17 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0114-2016
Date of alert
2015-09-17
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Stryker Craniomaxillofacial Division
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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