FDA recall Z-2239-2019

Product

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.

Reason for recall

Manufacturing flaw in the sterile barrier system

Distribution

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

Key facts

Status

Terminated

Initiation date

2019-06-25

Report date

2019-08-21

Termination date

2020-05-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Port Huron, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2239-2019