medical Class II Updated 2019-08-14

Ideal Implant Incorporated recalls IDEAL IMPLANT Structured Breast Implant, saline breast impla

Recalled 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.


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Serial numbers between 0100292 and 0102777.
View official government recall

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