Reported Dec 25, 2019 · Terminated
Natrelle Inspira Sillicone-Filled Breast Implants for the following Styles and Sizes
Allergan PLC
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Allergan PLC · 2525 Dupont Dr · Irvine, CA · 92612-1531
Is this the product you have?
Natrelle Inspira Sillicone-Filled Breast Implants for the following Styles and Sizes
71 of 71 products
| Model / number | Product as published |
|---|---|
10888628032835 | Natrelle Inspira Sillicone-Filled Breast Implants for the following Styles and Sizes: 7607 SSM, 7608 SSF, 7609 SSX, 7513 SRL, 7514 SRLP, 7515 SRM, 7516 SRF, 7517 SRX, 7626 SCL, 7627 SCLP, 7628 SCM, 7629 SCF, 7630 SCX: 7607 SSM/UDI: Natrelle Inspira SSM 140cc BI (US) |
10888628032842 | Natrelle Inspira SSM 175cc BI (US) |
10888628032859 | Natrelle Inspira SSM 195cc BI (US) |
10888628032866 | Natrelle Inspira SSM 210cc BI (US) |
10888628032873 | Natrelle Inspira SSM 240cc BI (US) |
10888628032880 | Natrelle Inspira SSM 255cc BI (US) |
10888628032897 | Natrelle Inspira SSM 275cc BI (US) |
10888628032903 | Natrelle Inspira SSM 295cc BI (US) |
10888628032910 | Natrelle Inspira SSM 310cc BI (US) |
10888628032927 | Natrelle Inspira SSM 330cc BI (US) |
10888628032934 | Natrelle Inspira SSM 345cc BI (US) |
10888628032941 | Natrelle Inspira SSM 360cc BI (US) |
10888628032958 | Natrelle Inspira SSM 375cc BI (US) |
10888628032965 | Natrelle Inspira SSM 405cc BI (US) |
10888628032972 | Natrelle Inspira SSM 445cc BI (US) |
10888628032989 | Natrelle Inspira SSM 485cc BI (US) |
10888628032996 | Natrelle Inspira SSM 520cc BI (US) |
10888628033009 | Natrelle Inspira SSM 560cc BI (US) |
10888628033016 | Natrelle Inspira SSM 600cc BI (US) |
10888628033023 | Natrelle Inspira SSM 640cc BI (US) |
- Lot codes and dates
- MFG BATCHES
3,621 of 3,621 codes
280509628367862884422288999928717402878486279726428844263036126305907030764513124452313147931398823154328315749331732203176664321309732287432776706288442729090552921210300801730227333035530305946330810933096446312477331277743142976315456631570863157779316081731640793167339317366431769183182507320386732082833211090322612528308602868178288442829177762958518296180230160933019001303626130592683076606309171330940373124627
- MFG BATCHES
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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