FDA-Device2019-08-21Class II
K-Wire Single Trocar 2.5x170mm, Item Number OL17025S - 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
350 units
Manufactured in
2929 Lapeer Rd, N/A, Port Huron, MI, United States
Products
K-Wire Single Trocar 2.5x170mm, Item Number OL17025S - 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-2242-2019Don't want to check this manually?
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