Neodent Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 -intended for dental implant Item 138.089
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot GNV17 UDI: 7899878052722
- 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:
- Mislabeled: Carton box item 138.089- Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 has an implant with measure of 3.5x13mm; and Carton Box (138.107- Easypack Helix GM Acqua has a 3.5x8mm implant instead of a 3.5x 13mm implant
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Neodent Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 -intended for dental implant Item 138.089
Product Codes/Lot Numbers:
Lot GNV17 UDI: 7899878052722
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0512-2022
Related Recalls
Class I - Dangerous
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
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Class I - Dangerous
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;
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Class I - Dangerous
The referred batch was produced without the laser engraving of 7 mm.