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Zimmer, Inc. recalls Moore Hip Prosthesis Long Fenestrated Stem, several head Diameter, 203 mm Stem length. Used to seat the prosthesis wi
Recalled August 28, 2013 · FDA recall Z-1981-2013 · Zimmer
Hazard
Zimmer recently conducted a review of historic packaging validations completed. Based on this review, it was determined that a subset of product packaged at a single 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 single packaging tray configuration, which · FDA Class II
Units
1,710 units are in distribution
Sold at
Worldwide Distribution-USA (nationwide) including the states of CT, FL, GA, IL, IN, KS, KY, MA, MI, MN, MT, NC, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VI, and WI, and the countries of Singapore, Canada, Mexico, Arab Emirates, Saudi Arabia, and Hong Kong.
Description
Zimmer recently conducted a review of historic packaging validations completed. Based on this review, it was determined that a subset of product packaged at a single 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 single packaging tray configuration, which
Product
Moore Hip Prosthesis Long Fenestrated Stem, several head Diameter, 203 mm Stem length. Used to seat the prosthesis with or without bone cement.
Manufacturer(s)
Zimmer, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →