K-Wire Single Trocar 1.1x150mm, Item Number OL15011S - 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 - M209OL15011S0 Lot Number - 123220 MFG Date - 4/23/2019

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