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U.S. Department of Health and Human Services

Enforcement Report - Week of July 10, 2013

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Product Detail

Product Description Bigliani/Flatow® The Complete Solution Fukuda Retractors Small Nonsterile 00-4305-019-30. Used in retracting the humeral shaft posteriorly and exposing the entire glenoid surface.
Recall Number Z-1621-2013
Classification Class II
Code Info Item Number 00-4305-019-30 with Lot Numbers 61557761, 61591732, 61612275, 61614764, and 77000186. 2010 Market Withdrawal part numbers: Item #:430501930, Lot#s: 60795817, 60834923, 60916795, 60997103, 61017041, 61038697, 61075510, 61128521, 61186400, 61199809, 61253702, 61392455, 61430126
Product Distributed Qty 722 units (includes 2010 market withdrawal)
Reason For Recall This is a recall expansion from the 2010 recall which now includes seven additional lots that were not previously included. Zimmer, Inc. is initiating a recall of small and large Fukuda-type retractors due to fractures occurring at the grooves around the perimeter of the blades while being used during surgery.

Event Detail

Event Id 65301
Product Type Devices
Status Ongoing
Recalling Firm Zimmer, Inc.
City Warsaw
State IN
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-05-23
Initial Firm Notification of Consignee or Public Telephone
Distribution Pattern Worldwide Distribution-USA (nationwide) including the states of NY, MI, MN, OH, IN, IL, VA, MD, PA, WA, KY, CT, RI, NH, TX, MT, and CA and the countries of Chile, China, South Korea, and Australia.