IDEAL IMPLANT Structured Breast Implant, saline breast implant, in the following sizes: 210cc, 240cc, 270cc, 300cc, 335cc, 370cc, 405cc, 440cc, 475cc, 515cc, 555cc, 595cc, 635cc, and 675cc.
Class I - Dangerous 🏥 Medical Devices
Recalled: March 18, 2019 Ideal Implant Incorporated Implants & Prosthetics
Nationwide
What Should You Do?
- Check if you have this product: Serial numbers between 0100292 and 0102777.
- 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:
- Ideal Implant Incorporated
- Reason for Recall:
- The implants were deflating due to a piece of silicone disrupting the seal of the posterior valve shortly after implantation.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
IDEAL IMPLANT Structured Breast Implant, saline breast implant, in the following sizes: 210cc, 240cc, 270cc, 300cc, 335cc, 370cc, 405cc, 440cc, 475cc, 515cc, 555cc, 595cc, 635cc, and 675cc.
Product Codes/Lot Numbers:
Serial numbers between 0100292 and 0102777.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2219-2019