# FDA recall Z-2219-2019

> **Ideal Implant Incorporated** · Class II · device recall initiated 2019-03-18.

## 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.

## Reason for recall

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

## Distribution

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.

## Key facts

- **Recall number:** Z-2219-2019
- **Recalling firm:** Ideal Implant Incorporated
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-03-18
- **Report date:** 2019-08-14
- **Termination date:** 2021-03-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Dallas, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2219-2019

## Citation

> AI Analytics. FDA recall Z-2219-2019. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-2219-2019. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*