FDA recall Z-0699-2020

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

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

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0699-2020