# FDA recall Z-2455-2019

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

## Product

Natrelle 133 Tissue Expanders (also named style 133 BIOSPAN Tissue Expander and Mcghan Magna-Site Tissue Expander) BioCell Full Height Variable Projection with Magna-Fider Xact & 21G Needle Infusion Set, Sterile, for the following style numbers:    STYLE 133FV:  133FV-11,  133FV-12,  133FV-13,  133FV-14,  133FV-15,  133FV-16;    STYLE 133MV:  133MV-11,  133MV-12,  133MV-13,  133MV-14,  133MV-15,  133MV-16;      STYLE 133LV:  133LV-11,  133LV-12,  133LV-13,  133LV-14,  133LV-15,  133LV-16;      STYLE 133FX:  133FX-11  133FX-12  133FX-13  133FX-14  133FX-15  133FX-16    STYLE 133MX:  133MX-11,  133MX-12,  133MX-13,  133MX-14,  133MX-15,  133MX-16;      STYLE 133SX:  133SX-11,  133SX-12,  133SX-13,  133SX-14,  133SX-15,  133SX-16;      STYLE 133SV:  133SV-11,  133SV-12,  133SV-13,  133SV-14,  133SV-15,  133SV-16;    These products may have been sold under the McGhan, Inamed or NATRELLE brands.      Product Usage:   intended for temporary subcutaneous implantation and require periodic, inc

## 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-2455-2019
- **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-2455-2019

## Citation

> AI Analytics. FDA recall Z-2455-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-2455-2019. Source: US FDA. Licensed CC0.

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