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Zimmer, Inc. recalls VerSys¿ Hip System, Beaded Fullcoat Stems, Zimmer, Inc., Warsaw, IN 46581
Recalled July 2, 2014 · FDA recall Z-1842-2014 · Zimmer
Hazard
During routine inspection, beaded hip stem forgings received from supplier failed to meet ZES 2A-102. Processing of Beaded CoCrMo Alloy Hip Stem, material requirements per ATS #14-04818 and ATS #14-05549, respectively. · FDA Class II
Units
147 units
Sold at
Worldwide Distribution-USA (nationwide) including the states of AL, AZ, CA, CO, CT, FL, GA, IL, IN, MA, MI, MN, NC, ND, NJ, NY, OH, OK, PA, TN, TX, VA & WI, and the countries of Canada, Colombia, Dominican Republic, Japan, Korea (S. Korea), Peru, Taiwan & Thailand.
Description
During routine inspection, beaded hip stem forgings received from supplier failed to meet ZES 2A-102. Processing of Beaded CoCrMo Alloy Hip Stem, material requirements per ATS #14-04818 and ATS #14-05549, respectively.
Product
VerSys¿ Hip System, Beaded Fullcoat Stems, Zimmer, Inc., Warsaw, IN 46581
Manufacturer(s)
Zimmer, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →