Z-2254-2019 Class II Terminated
FDA device recall Z-2254-2019 was initiated by BioPro, Inc. on June 25, 2019 and is designated Class II. Reason for recall: Manufacturing flaw in the sterile barrier system The recall status is terminated (terminated May 7, 2020). Affected quantity: 3 units.
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
- 3 units
Product Description
Go-EZ Screw 6.5x32, Item Number 19652 - 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 - M209196520 Lot Number - 123106 MFG Date - 4/26/2019