FDAFDA · Food and drugs·Recall number Z-2258-2019
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
Published August 21, 2019 · Recall initiated: June 25, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Manufacturing flaw in the sterile barrier system
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- BioPro, Inc.
- Distributor
- Worldwide distribution - US Nationwide distribution in the states of FL, LA, MD, NC, NY, OR & TX, and countries of Ecuador, Scotland.
- Lot
- UDI - M209196550 Lot Number - 123109 MFG Date - 4/26/2019
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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