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Stryker Instruments Div. of Stryker Corporation recalls 180-Gram Cement Cartridge with Breakaway Femoral Nozzle, Product Number: 0206-530-000, UDI: (01)4546540857880 for o
Recalled April 4, 2018 · FDA recall Z-1244-2018 · Stryker Instruments Div. of Stryker
Hazard
Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates. · FDA Class II
Units
708
Sold at
Distributed in all 50 U.S. States and the District of Columbia. Distributed in Australia, Argentina, Japan, Canada, Chile, Korea, Spain, France, Italy, Netherlands, and United Kingdom.
Description
Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
Product
180-Gram Cement Cartridge with Breakaway Femoral Nozzle, Product Number: 0206-530-000, UDI: (01)4546540857880 for orthopedic use.
Manufacturer(s)
Stryker Instruments Div. of Stryker Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →