Reported Dec 25, 2019 · Terminated
Natrelle Silicone 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 Silicone Filled Breast Implants for the following Styles and Sizes
66 of 66 products
| Model / number | Product as published |
|---|---|
10888628001206 | 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 |
10888628001213 | NATRELLE Style 10-210 Gel Round Mod |
10888628001220 | NATRELLE Style 10-240 Gel Round Mod |
10888628001237 | NATRELLE Style 10-270 Gel Round Mod |
10888628001244 | NATRELLE Style 10-300 Gel Round Mod |
10888628001251 | NATRELLE Style 10-330 Gel Round Mod |
10888628001268 | NATRELLE Style 10-360 Gel Round Mod |
10888628001275 | NATRELLE Style 10-390 Gel Round Mod |
10888628001282 | NATRELLE Style 10-420 Gel Round Mod |
10888628001299 | NATRELLE Style 10-450 Gel Round Mod |
10888628001312 | NATRELLE Style 10-510 Gel Round Mod |
10888628001374 | NATRELLE Style 10-800 Gel Round Mod |
10888628001381 | Style 15/UDI: NATRELLE Style 15-158 Gel Round Mod Plus |
10888628001398 | NATRELLE Style 15-176 Gel Round Mod Plus |
10888628001404 | NATRELLE Style 15-194 Gel Round Mod Plus |
10888628001411 | NATRELLE Style 15-213 Gel Round Mod Plus |
10888628001428 | NATRELLE Style 15-234 Gel Round Mod Plus |
10888628001435 | NATRELLE Style 15-265 Gel Round Mod Plus |
10888628001442 | NATRELLE Style 15-286 Gel Round Mod Plus |
10888628001459 | NATRELLE Style 15-304 Gel Round Mod Plus |
- 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.
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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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