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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