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Zimmer, Inc. recalls Bigliani/Flatow¿ The Complete Solution Fukuda Retractors Small Nonsterile 00-4305-019-30. Used in retracting the hum
Recalled July 10, 2013 · FDA recall Z-1621-2013 · Zimmer
Hazard
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 Class II
Units
722 units (includes 2010 market withdrawal)
Sold at
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.
Description
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.
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.
Manufacturer(s)
Zimmer, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →