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Howmedica Osteonics Corp. recalls Custom Made Implant System with Minimum Invasive Grower (MIG) component
Recalled August 8, 2018 · FDA recall Z-2567-2018 · Howmedica Osteonics
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. · FDA Class II
Units
5
Sold at
NY, FL, KS
Description
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.
Product
Custom Made Implant System with Minimum Invasive Grower (MIG) component
Manufacturer(s)
Howmedica Osteonics Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →