Ideal Implant Incorporated: Medical Device Recall in 2019 - (Recall #: Z-2219-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: March 18, 2019

Date Posted: August 14, 2019

Recall Number: Z-2219-2019

Event ID: 83251

Reason for Recall:

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

Status: Terminated

Product Quantity: 1,704 implants

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.

Voluntary or Mandated:

Voluntary: Firm initiated