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Zimmer, Inc. recalls FEM COND BUTTRESS PLT, RT.
Recalled January 8, 2014 · FDA recall Z-0585-2014 · Zimmer
Hazard
Based on a review of historic packaging validations, it was determined that a subset of product packaged at a 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 packaging tray configuration which consists of an inner and outer sterile tray, resulted in failure · FDA Class II
Units
42, 065 units total
Sold at
Worldwide Distribution.
Description
Based on a review of historic packaging validations, it was determined that a subset of product packaged at a 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 packaging tray configuration which consists of an inner and outer sterile tray, resulted in failure
Product
FEM COND BUTTRESS PLT, RT.
Manufacturer(s)
Zimmer, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →