Go-EZ Screw 6.5x95, Item Number 19667 - 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
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI - M209196670 Lot Number - 123114 MFG Date - 4/25/2019
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- BioPro, Inc.
- Reason for Recall:
- Manufacturing flaw in the sterile barrier system
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Go-EZ Screw 6.5x95, Item Number 19667 - 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
Product Codes/Lot Numbers:
UDI - M209196670 Lot Number - 123114 MFG Date - 4/25/2019
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2249-2019
Related Recalls
Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.
Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.
Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.