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

Recall Z-0590-2014 — NGK Stem Ext 24 x 245mm

U.S. FDA — Device Enforcement · United States · 2013-11-05 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0590-2014
Date of alert
2013-11-05
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Zimmer, Inc.
Product category
device
Product type
Devices
Reported risk: Based on a review of historic packaging validations, it was determined that a subset of product packaged at a Zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity. This testing determined that a packaging tray configuration which consists of an inner and outer sterile tray, resulted in failure
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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