FDA-Device2019-08-14Class II
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.
Ideal Implant Incorporated
Hazard
The implants were deflating due to a piece of silicone disrupting the seal of the posterior valve shortly after implantation.
Sold states
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.
Affected count
1,704 implants
Manufactured in
14881 Quorum Dr Ste 925, N/A, Dallas, TX, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2219-2019Don't want to check this manually?
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