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High RiskFDAfda-Z-2219-2019OTHER

IDEAL IMPLANT Structured Breast Implant, saline breast implant, in the following sizes: 210cc, 240cc, 270cc, 300cc, 335cc, 370cc, 405cc...

Units Affected
1,704
Recall Date
March 18, 2019
Issuing Agency
Hazard
Other

FDA Recall Notice

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2219-2019.

The implants were deflating due to a piece of silicone disrupting the seal of the posterior valve shortly after implantation.

Corrective Action (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2219-2019.

Recall terminated by FDA.

✅ What you should do

  1. Stop using the product if you own it.
  2. Check the model number, lot code, or sell-by date against the recall notice above.
  3. Contact Ideal Implant Incorporated or the retailer where you bought it for a refund, replacement, or repair.
  4. For the most current official instructions, visit the FDA recall page.
  5. If you've been hurt by this product, report the incident to FDA.

Consumer Contact (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2219-2019.

Ideal Implant Incorporated

FDA

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Ideal Implant Incorporated Recall FAQ

Ideal Implant Incorporated is the subject of a medical implants safety report: IDEAL IMPLANT Structured Breast Implant, saline breast implant, in the following sizes: 210cc, 240cc, 270cc, 300cc, 335cc, 370cc, 405cc.... The notice was published on March 18, 2019 by the U.S. Food and Drug Administration (FDA). Approximately 1,704 units are potentially affected.