FDA-Device2018-08-08Class II
Custom Made Implant System with Minimum Invasive Grower (MIG) component
Howmedica Osteonics Corp.
Hazard
From March 2007 to October 2014, product did not contain updated instructions for use (IFU) to clarify the function of locking mechanism and warnings related to the locking screw.
Sold states
NY, FL, KS
Affected count
5
Manufactured in
325 Corporate Dr, N/A, Mahwah, NJ, United States
Products
Custom Made Implant System with Minimum Invasive Grower (MIG) component
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2567-2018Don't want to check this manually?
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