Z-2247-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 21, 2019
- Initiation Date
- June 25, 2019
- Termination Date
- May 7, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4 units
Product Description
Go-EZ Screw 6.5x100, Item Number 19668 - 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 Pattern
Worldwide distribution - US Nationwide distribution in the states of FL, LA, MD, NC, NY, OR & TX, and countries of Ecuador, Scotland.
Code Information
UDI - M209196680 Lot Number - 123115 MFG Date - 4/26/2019