Skip to content
Recall Observatory FDA recall evidence

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

March 18, 2019

Class II

Product summary

Firm
Ideal Implant Incorporated
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

    reason.no_named_rule · v1.0.0

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