FDA-Device2019-08-21Class II
K-Wire HBS Sterile, Item Number 19688 - 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
17 units
Manufactured in
2929 Lapeer Rd, N/A, Port Huron, MI, United States
Products
K-Wire HBS Sterile, Item Number 19688 - 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-2239-2019Don't want to check this manually?
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