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U.S. Department of Health and Human Services

Class 2 Device Recall Bigliani/Flatow

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 Class 2 Recall
Bigliani/Flatow
see related information
Date Posted July 01, 2013
Recall Status1 Open
Recall Number Z-1621-2013
Recall Event ID 65301
Product Classification Orthopedic Manual Surgical Instrument - Product Code LXH
Product 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.
Code Information 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
Recalling Firm/
Manufacturer
Zimmer, Inc.
345 E Main St
Warsaw, Indiana 46580-2746
Manufacturer 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.
FDA Determined
Cause 2
DESIGN: Device Design
Action In 2010, Zimmer initiated a recall of the Bigliani/Flatow® Fukuda Retractors due to fractures occurring at the grooves around the perimeter of the blades. Zimmer is expanding this recall to include seven lots that were not previously included. On 5/23/13, an Urgent Medical Device Recall notification letter went to all consignees explaining the recall expansion and risk associated with the recall. All consignees are to locate and quarantine the device immediately. Please return the product along with the completed inventory certification form to Zimmer. If you have any questions regarding this recall, call Zimmer at 877-946-2761.
Quantity in Commerce 722 units (includes 2010 market withdrawal)
Distribution 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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