GM Helix Acqua Implant, Article Number: 140.985
Class I - DangerousWhat Should You Do?
- Check if you have this product: Article Number: 140.985; UDI-DI: (01)7899878024569(11)220125(17)270124(10)JPZ75; Lot number: JPZ75;
- 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:
- Straumann USA LLC
- Reason for Recall:
- It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
GM Helix Acqua Implant, Article Number: 140.985
Product Codes/Lot Numbers:
Article Number: 140.985; UDI-DI: (01)7899878024569(11)220125(17)270124(10)JPZ75; Lot number: JPZ75;
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1863-2025
Related Recalls
The possibility for this product that is intended for demonstration purposes only to be placed in patients.
GM Helix Acqua Implant, Article Number: 140.984
Straumann USA
It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.
Plus Initial Drill, Article Number: 103.170;
Straumann USA
The referred batch was produced without the laser engraving of 7 mm.