SuperElastic Regular force NiTi lower or upper Natural arches. 0.14 size 10 or 100 count packages. Highland Metals Inc. San Jose, CA The devices are intended to provide force to the teeth to effect movement in order to alter their position.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Part Number Part Description Lot Number Label Form Actual Form 11100141124 SE Niti 014 Nat U 100 41756 Upper Lower 11100141144 SE Niti 014 Nat L 100 41760 Lower Upper 11100141145 SE Niti 014 Nat L 10 41760 Lower Upper
- 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:
- Highland Metals, Inc.
- Reason for Recall:
- Labeling issue: Product labeled as "Upper" may contain "Lower" archwires with a red midline mark. Product labeled ad "Lower" may contain "Upper" archwires with a black midline mark.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
SuperElastic Regular force NiTi lower or upper Natural arches. 0.14 size 10 or 100 count packages. Highland Metals Inc. San Jose, CA The devices are intended to provide force to the teeth to effect movement in order to alter their position.
Product Codes/Lot Numbers:
Part Number Part Description Lot Number Label Form Actual Form 11100141124 SE Niti 014 Nat U 100 41756 Upper Lower 11100141144 SE Niti 014 Nat L 100 41760 Lower Upper 11100141145 SE Niti 014 Nat L 10 41760 Lower Upper
Distribution:
Distributed in: IL, KY, MI, NY, CA, FL, LA
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0923-2014
Related Recalls
Labeling issue: Product labeled as "Upper" may contain "Lower" archwires with a red midline mark. Product labeled ad "Lower" may contain "Upper" archwires with a black midline mark.