K-Wire Sterile Single Trochar .045, Item Number 19108 - 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

Reason: Manufacturing flaw in the sterile barrier system

Code information: UDI - M209191080 Lot Number - 123131 MFG Date - 4/2/2019

Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of FL, LA, MD, NC, NY, OR & TX, and countries of Ecuador, Scotland.