# FDA recall Z-2456-2019

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

## Product

Natrelle133 Plus Tissue Expander With/Without Suture Tabs, BioCell Full Height Variable Projection with Magna-Fider Xact & 21G Needle Infusion Set, Sterile, for the following style numbers:    STYLE 133P-FV:  133P-FV-11,  133P-FV-12,  133P-FV-13,  133P-FV-14,  133P-FV-15,  133P-FV-16;    STYLE 133P-MV:  133P-MV-11,  133P-MV-12,  133P-MV-13,  133P-MV-14,  133P-MV-15,  133P-MV-16;    STYLE 133P-LV:  133P-LV-11, 133P-LV-12, 133P-LV-13, 133P-LV-14, 133P-LV-15, 133P-LV-16;  STYLE 133P-FX: 133P-FX-11, 133P-FX-12, 133P-FX-13, 133P-FX-14, 133P-FX-15, 133P-FX-16;  STYLE 133P-MX:133P-MX-11,133P-MX-12, 133P-MX-13, 133P-MX-14, 133P-MX-15, 133P-MX-16;  STYLE 133P-SX: 133P-SX-11,  133P-SX-12,  133P-SX-13,  133P-SX-14,  133P-SX-15, 133P-SX-16;  STYLE 133P-SV: 133P-SV-11,133P-SV-12, 133P-SV-13, 133P-SV-14, 133P-SV-15, 133P-SV-16;  STYLE 133P-FV-T:133P-FV-11-T, 133P-FV-12-T, 133P-FV-13-T, 133P-FV-14-T, 133P-FV-15-T, 133P-FV-16-T;  STYLE 133P-MV-T:  133P-MV-11-T,  133P-MV-12-T,  133P-MV-13-T,  133P-MV-1

## 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-2456-2019
- **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-2456-2019

## Citation

> AI Analytics. FDA recall Z-2456-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-2456-2019. Source: US FDA. Licensed CC0.

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