Medical device recalls Moderate risk

Howmedica Osteonics Corp. recalls Custom Made Implant System with Minimum Invasive Grower (MIG) component

Recall date
December 21, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2567-2018
FDA classification
Class II
Brand / firm
Howmedica Osteonics Corp.
Sold / distributed
NY, FL, KS

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Custom Made Implant System with Minimum Invasive Grower (MIG) component

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