Ideal Implant Incorporated recalls IDEAL IMPLANT Structured Breast Implant, saline breast implant, in the following sizes: 210cc, 240cc, 270cc, 300cc, 335…

Recall date

March 18, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2219-2019

FDA classification

Class II

Brand / firm

Ideal Implant Incorporated

Sold / distributed

Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, NC, ND, NH, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WV. Country of Canada.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.