# FDA recall Z-0699-2020

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

## Product

Natrelle Saline-Filled Breast Implant, for the following Styles and sizes, Style LP, Style 68 HP, Style 68 MP,     Style LP/UDI:  NATRELLE Style 68LP-125 Saline Round Low	10888628000513,  NATRELLE Style 68LP-150 Saline Round Low	10888628000520,  NATRELLE Style 68LP-175 Saline Round Low	10888628000537,  NATRELLE Style 68LP-200 Saline Round Low	10888628000544,  NATRELLE Style 68LP-225 Saline Round Low	10888628000551,  NATRELLE Style 68LP-250 Saline Round Low	10888628000568,  NATRELLE Style 68LP-275 Saline Round Low	10888628000575,  NATRELLE Style 68LP-300 Saline Round Low	10888628000582,  NATRELLE Style 68LP-325 Saline Round Low	10888628000599,  NATRELLE Style 68LP-350 Saline Round Low	10888628000605,  NATRELLE Style 68LP-400 Saline Round Low	10888628000612,  NATRELLE Style 68LP-420 Saline Round Low	10888628000629,  NATRELLE Style 68LP-440 Saline Round Low	10888628000636,  NATRELLE Style 68LP-480 Saline Round Low	10888628000643,  NATRELLE Style 68LP-525 Saline Round Low	10888628000650,  

## 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-0699-2020
- **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-0699-2020

## Citation

> AI Analytics. FDA recall Z-0699-2020. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/Z-0699-2020. Source: US FDA. Licensed CC0.

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