Custom Made Implant System with Minimum Invasive Grower (MIG) component
FDA Recall #Z-2567-2018 — Class II — December 21, 2017
Product Description
Custom Made Implant System with Minimum Invasive Grower (MIG) component
Reason for Recall
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.
Recalling Firm
Howmedica Osteonics Corp. — Mahwah, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
5
Distribution
NY, FL, KS
Code Information
Manufactured between March 2007 and October 2014 Prosthesis Identification Number (PIN) Date of Dispatch 16082 11Apr 2011 18313 19 Dec 2013 18666 20 Jun 2014 18713 15 Sep 2014 18800 29 Aug 2014
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated