# FDA recall Z-2451-2019

> **Allergan PLC** · Class I · device recall initiated 2019-07-24.

## Product

Natrelle, Saline-Filled Breast Implant Biocell Full Height with Fill Tube, Sterile,  for the following style numbers:    Style 163:163-360CC, 163-440CC, 163-530CC, 163-655CC, 163-780CC;    Style 168:168-120,168-150,168-180,168-210,168-240,168-270,168-300,168-330,168-360,168-390,168-420,168-450,168-480,168-510,168-550,168-600, 168-650,168-700,168-750, 168-800;    Style 363: 363LF-170, 363LF-200, 363LF-230, 363LF-260, 363LF-300, 363LF-330, 363LF-370, 363LF-410, 363LF-450, 363LF-510, 363LF-560, 363LF-620, 363LF-690;    Syle 468: 468-195, 468-230, 468-270, 468-300, 468-350, 468-380, 468-450, 468-495, 468-560, 468-620    These products may have been sold under the McGhan, Inamed or NATRELLE brands.      Product Usage:  Breast augmentation and Breast reconstruction

## Reason for recall

The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.

## Distribution

Worldwide Distribution and US Nationwide     All fifty (50) US States,  the US Virgin Islands and Puerto Rico.  (AK, AL, AR, AZ, CA,  CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY).    OUS: Bermuda, Canada, Chile, Japan, Korea, Thailand, Taiwan and Vietnam.

## Key facts

- **Recall number:** Z-2451-2019
- **Recalling firm:** Allergan PLC
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2019-07-24
- **Report date:** 2019-09-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Irvine, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2451-2019

## Citation

> AI Analytics. FDA recall Z-2451-2019. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-2451-2019. Source: US FDA. Licensed CC0.

---

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