# FDA recall Z-0700-2020

> **Allergan PLC** · Class III · device recall initiated 2019-11-06.

## Product

Natrelle Silicone Filled Breast Implants for the following Styles and Sizes: Style 10, Style 15, Style 20, Style 40, Style 45    Style 10/UDI:  NATRELLE Style 10-180 Gel Round Mod	10888628001206,  NATRELLE Style 10-210 Gel Round Mod	10888628001213,  NATRELLE Style 10-240 Gel Round Mod	10888628001220,  NATRELLE Style 10-270 Gel Round Mod	10888628001237,  NATRELLE Style 10-300 Gel Round Mod	10888628001244,  NATRELLE Style 10-330 Gel Round Mod	10888628001251,  NATRELLE Style 10-360 Gel Round Mod	10888628001268,  NATRELLE Style 10-390 Gel Round Mod	10888628001275,  NATRELLE Style 10-420 Gel Round Mod	10888628001282,  NATRELLE Style 10-450 Gel Round Mod	10888628001299,  NATRELLE Style 10-510 Gel Round Mod	10888628001312,  NATRELLE Style 10-800 Gel Round Mod	10888628001374,  Style 15/UDI:  NATRELLE Style 15-158 Gel Round Mod Plus	10888628001381,  NATRELLE Style 15-176 Gel Round Mod Plus	10888628001398,  NATRELLE Style 15-194 Gel Round Mod Plus	10888628001404,  NATRELLE Style 15-213 Gel Round

## Reason for recall

The firm has became aware that 2D barcodes on breast implants and sizers may be unreadable by GS-1 configured scanners. These 2D barcodes contain a group separators between fixed-length element string in the UDI data chain of the 2D barcode, which is not formatted to the GS1 standard.

## Distribution

US:AL, AR,AZ,CA,CO,DC,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,PR,RI,SC,SD,TN,TX,UT,VA,WA,WI,WY

## Key facts

- **Recall number:** Z-0700-2020
- **Recalling firm:** Allergan PLC
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-11-06
- **Report date:** 2019-12-25
- **Termination date:** 2021-07-09

- **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-0700-2020

## Citation

> AI Analytics. FDA recall Z-0700-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0700-2020. Source: US FDA. Licensed CC0.

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