FDA-Device2018-04-04Class II
Advanced Cement Mixing (ACM) Kit w/ Femoral Breakaway Nozzle & Prox. Med. Press., Product Number: 0306-573-000, UDI: (01)4546540055415 for orthopedic use.
Stryker Instruments Div. of Stryker Corporation
Hazard
Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
Sold states
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.
Affected count
1542
Manufactured in
4100 E Milham Ave, Portage, MI, United States
Products
Advanced Cement Mixing (ACM) Kit w/ Femoral Breakaway Nozzle & Prox. Med. Press., Product Number: 0306-573-000, UDI: (01)4546540055415 for orthopedic use.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1248-2018Don't want to check this manually?
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