Home / Recalls / Medical Devices
Stryker Instruments Div. of Stryker Corporation recalls Revolution 90 Degree Tibial Nozzle, Product Number: 0606-516-000, UDI: (01)4546540911971 for orthopedic use.
Recalled April 4, 2018 · FDA recall Z-1251-2018 · 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
30
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 90 Degree Tibial Nozzle, Product Number: 0606-516-000, UDI: (01)4546540911971 for orthopedic use.
Manufacturer(s)
Stryker Instruments Div. of Stryker Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →