Home / Recalls / Medical Devices
Ideal Implant Incorporated recalls IDEAL IMPLANT Structured Breast Implant, saline breast implant, in the following sizes: 210cc, 240cc, 270cc, 300cc, 33
Recalled August 14, 2019 · FDA recall Z-2219-2019 · Ideal Implant Incorporated
Hazard
The implants were deflating due to a piece of silicone disrupting the seal of the posterior valve shortly after implantation. · FDA Class II
Units
1,704 implants
Sold at
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.
Description
The implants were deflating due to a piece of silicone disrupting the seal of the posterior valve shortly after implantation.
Product
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.
Manufacturer(s)
Ideal Implant Incorporated
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →