FDA-Device2018-04-04Class II
1. AutoPlex System, Product Number: 0605-887-000, UDI: (01)4546540593108; 2. AutoPlex System: w/ VertaPlex HV, Product Number: 0607-687-000, UDI: (01)7613252039259 Bone cement.
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
1244
Manufactured in
4100 E Milham Ave, Portage, MI, United States
Products
1. AutoPlex System, Product Number: 0605-887-000, UDI: (01)4546540593108; 2. AutoPlex System: w/ VertaPlex HV, Product Number: 0607-687-000, UDI: (01)7613252039259 Bone cement.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1250-2018Don't want to check this manually?
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