# FDA recall Z-0702-2020

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

## Product

NATRELLE Resterilizable Sizers for the styles and sizes: Style 15, Style 20, Inspira X (responsive gel), Inspira F (responsive gel), Inspira LP (responsive gel), Inspira M (responsive gel), Inspira L (responsive gel), Inspira ST L (Soft Touch gel), Inspira ST LP (Soft Touch Gel), Inspira ST M (Soft Touch Gel), Inspira ST F (Soft Touch Gel), Inspira ST X (Soft Touch Gel)    Style 10/UDI:  NATRELLE Sty 10-360 Rstrl Sizer Gel Mod	10888628005587  NATRELLE Sty 10-390 Rstrl Sizer Gel Mod	10888628005594  NATRELLE Sty 10-420 Rstrl Sizer Gel Mod	10888628005600  NATRELLE Sty 10-450 Rstrl Sizer Gel Mod	10888628005617  NATRELLE Sty 10-480 Rstrl Sizer Gel Mod	10888628005624  NATRELLE Sty 10-510 Rstrl Sizer Gel Mod	10888628005631  NATRELLE Sty 10-700 Rstrl Sizer Gel Mod	10888628005679  NATRELLE Sty 10-750 Rstrl Sizer Gel Mod	10888628005686  NATRELLE Sty 10-800 Rstrl Sizer Gel Mod	10888628005693    Style 15/UDI:  NATRELLE Sty 15-304 Rstrl Sizer Gel Mid	10888628005778  NATRELLE Sty 15-339 Rstrl Sizer 

## 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-0702-2020
- **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-0702-2020

## Citation

> AI Analytics. FDA recall Z-0702-2020. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-0702-2020. Source: US FDA. Licensed CC0.

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