Device 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.
Z-2219-2019
Product summary
- Event
- Event 83251
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,704 implants
- Official record key
device-enforcement:Z-2219-2019
Official wording
Reason: The implants were deflating due to a piece of silicone disrupting the seal of the posterior valve shortly after implantation.
Code information: Serial numbers between 0100292 and 0102777.
Distribution pattern: 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.
Derived failure modes
-
Unknown
The implants were deflating due to a piece of silicone disrupting the seal of the posterior valve shortly after implantation.