FDA-Device2014-02-19Class II
Stryker Orthopaedics Navigation Compatible Accolade Broach Handle 1 single unit to a package Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 USA Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 Meyzieu Cedex France Made in USA non-sterile
Stryker Howmedica Osteonics Corp.
Hazard
Stryker received reports from the field of the impaction plate dissociating/fracturing from the main body of the broach handle.
Sold states
IL MA, MN, ND, OR, & PA
Affected count
211 units
Manufactured in
325 Corporate Dr, N/A, Mahwah, NJ, United States
Products
Stryker Orthopaedics Navigation Compatible Accolade Broach Handle 1 single unit to a package Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 USA Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 Meyzieu Cedex France Made in USA non-sterile
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0964-2014Don't want to check this manually?
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