Device product
Go-EZ Screw 6.5x38, Item Number 19655 - 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
Z-2258-2019
Product summary
- Firm
- BioPro, Inc.
- Event
- Event 83288
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3 units
- Official record key
device-enforcement:Z-2258-2019
Official wording
Reason: Manufacturing flaw in the sterile barrier system
Code information: UDI - M209196550 Lot Number - 123109 MFG Date - 4/26/2019
Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of FL, LA, MD, NC, NY, OR & TX, and countries of Ecuador, Scotland.
Derived failure modes
-
Unknown
Manufacturing flaw in the sterile barrier system