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Stryker Instruments Div. of Stryker Corporation recalls Revolution CMS w/ Femoral Breakaway Nozzle & Med. Press., Product Number: 0606-573-000, UDI: (01)4546540912114 for
Recalled April 4, 2018 · FDA recall Z-1252-2018 · 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
732
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
Revolution CMS w/ Femoral Breakaway Nozzle & Med. Press., Product Number: 0606-573-000, UDI: (01)4546540912114 for orthopedic use.
Manufacturer(s)
Stryker Instruments Div. of Stryker Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →