VGI Medical, LLC recalls VGI MEDICAL VerteLP LATERAL INTERBODY FUSION instrument kit
- Recall date
- April 9, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2100-2018
- FDA classification
- Class II
- Brand / firm
- VGI Medical, LLC
- Sold / distributed
- Distributed to MI, FL, and NY.
Why it was recalled
IFU contained an automated cleaning process for the VerteLP Instrument Tray that was not validated
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
VGI MEDICAL VerteLP LATERAL INTERBODY FUSION instrument kit
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