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U.S. Department of Health and Human Services

Enforcement Report - Week of January 8, 2014

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Product Detail

Product Description NGK Stem Ext 24 x 245mm
Recall Number Z-0590-2014
Classification Class II
Code Info Item Numbers: 32-5988-012-24 All lots with an expiration date prior to July 24, 2023
Product Distributed Qty 42, 065 units total
Reason For Recall 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 failures related to the visual quality of the seal (homogeneous adhesive transfer). This failure occurred on 3 of 154 tray samples tested and was observed on inner trays only. No physical failures in either peel strength or pressure testing were observed.

Event Detail

Event Id 66499
Product Type Devices
Status Ongoing
Recalling Firm Zimmer, Inc.
City Warsaw
State IN
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-11-05
Initial Firm Notification of Consignee or Public E-Mail
Distribution Pattern Worldwide Distribution.