FDA-Device2019-08-21Class II
Go-EZ Screw 6.5x100, Item Number 19668 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine
BioPro, Inc.
Hazard
Manufacturing flaw in the sterile barrier system
Sold states
Worldwide distribution - US Nationwide distribution in the states of FL, LA, MD, NC, NY, OR & TX, and countries of Ecuador, Scotland.
Affected count
4 units
Manufactured in
2929 Lapeer Rd, N/A, Port Huron, MI, United States
Products
Go-EZ Screw 6.5x100, Item Number 19668 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2247-2019Don't want to check this manually?
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