PlainRecalls
FDA Devices Low Class III Terminated

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-27

Reported: December 25, 2019 Initiated: November 6, 2019 #Z-0699-2020

Product Description

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, NATRELLE Style 68LP-550 Saline Round Low 10888628000667, NATRELLE Style 68LP-600 Saline Round Low 10888628000674, NATRELLE Style 68LP-640 Saline Round Low 10888628000681, NATRELLE Style 68LP-680 Saline Round Low 10888628000698, Style 68 HP/UDI: NATRELLE Style 68HP-160 Saline Round High 10888628000353, NATRELLE Style 68HP-200 Saline Round High 10888628000360, NATRELLE Style 68HP-240 Saline Round High 10888628000377, NATRELLE Style 68HP-280 Saline Round High 10888628000384, NATRELLE Style 68HP-320 Saline Round High 10888628000391, NATRELLE Style 68HP-350 Saline Round High 10888628000407, NATRELLE Style 68HP-400 Saline Round High 10888628000414, NATRELLE Style 68HP-425 Saline Round High 10888628000421, NATRELLE Style 68HP-465 Saline Round High 10888628000438, NATRELLE Style 68HP-500 Saline Round High 10888628000445, NATRELLE Style 68HP-550 Saline Round High 10888628000452, NATRELLE Style 68HP-600 Saline Round High 10888628000469, NATRELLE Style 68HP-650 Saline Round High 10888628000476, NATRELLE Style 68HP-700 Saline Round High 10888628000483, NATRELLE Style 68HP-750 Saline Round High 10888628000490, NATRELLE Style 68HP-800 Saline Round High 10888628000506, Style 68 MP/UDI: NATRELLE Style 68MP-120 Saline Round Mod 10888628000155, NATRELLE Style 68MP-150 Saline Round Mod 10888628000162, NATRELLE Style 68MP-180 Saline Round Mod 10888628000179, NATRELLE Style 68MP-210 Saline Round Mod 10888628000186, NATRELLE Style 68MP-240 Saline Round Mod 10888628000193, NATRELLE Style 68MP-270 Saline Round Mod 10888628000209, NATRELLE Style 68MP-300 Saline Round Mod 10888628000216, NATRELLE Style 68MP-330 Saline Round Mod 10888628000223, NATRELLE Style 68MP-360 Saline Round Mod 10888628000230, NATRELLE Style 68MP-390 Saline Round Mod 10888628000247, NATRELLE Style 68MP-420 Saline Round Mod 10888628000254, NATRELLE Style 68MP-450 Saline Round Mod 10888628000261, NATRELLE Style 68MP-480 Saline Round Mod 10888628000278, NATRELLE Style 68MP-510 Saline Round Mod 10888628000285, NATRELLE Style 68MP-550 Saline Round Mod 10888628000292, NATRELLE Style 68MP-600 Saline Round Mod 10888628000308, NATRELLE Style 68MP-650 Saline Round Mod 10888628000315, NATRELLE Style 68MP-700 Saline Round Mod 10888628000322, NATRELLE Style 68MP-750 Saline Round Mod 10888628000339, NATRELLE Style 68MP-800 Saline Round Mod 10888628000346,

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.

Details

Recalling Firm
Allergan PLC
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
Location
Irvine, CA

Frequently Asked Questions

What product was recalled? ▼
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, NATRELLE Style 68LP-550 Saline Round Low 10888628000667, NATRELLE Style 68LP-600 Saline Round Low 10888628000674, NATRELLE Style 68LP-640 Saline Round Low 10888628000681, NATRELLE Style 68LP-680 Saline Round Low 10888628000698, Style 68 HP/UDI: NATRELLE Style 68HP-160 Saline Round High 10888628000353, NATRELLE Style 68HP-200 Saline Round High 10888628000360, NATRELLE Style 68HP-240 Saline Round High 10888628000377, NATRELLE Style 68HP-280 Saline Round High 10888628000384, NATRELLE Style 68HP-320 Saline Round High 10888628000391, NATRELLE Style 68HP-350 Saline Round High 10888628000407, NATRELLE Style 68HP-400 Saline Round High 10888628000414, NATRELLE Style 68HP-425 Saline Round High 10888628000421, NATRELLE Style 68HP-465 Saline Round High 10888628000438, NATRELLE Style 68HP-500 Saline Round High 10888628000445, NATRELLE Style 68HP-550 Saline Round High 10888628000452, NATRELLE Style 68HP-600 Saline Round High 10888628000469, NATRELLE Style 68HP-650 Saline Round High 10888628000476, NATRELLE Style 68HP-700 Saline Round High 10888628000483, NATRELLE Style 68HP-750 Saline Round High 10888628000490, NATRELLE Style 68HP-800 Saline Round High 10888628000506, Style 68 MP/UDI: NATRELLE Style 68MP-120 Saline Round Mod 10888628000155, NATRELLE Style 68MP-150 Saline Round Mod 10888628000162, NATRELLE Style 68MP-180 Saline Round Mod 10888628000179, NATRELLE Style 68MP-210 Saline Round Mod 10888628000186, NATRELLE Style 68MP-240 Saline Round Mod 10888628000193, NATRELLE Style 68MP-270 Saline Round Mod 10888628000209, NATRELLE Style 68MP-300 Saline Round Mod 10888628000216, NATRELLE Style 68MP-330 Saline Round Mod 10888628000223, NATRELLE Style 68MP-360 Saline Round Mod 10888628000230, NATRELLE Style 68MP-390 Saline Round Mod 10888628000247, NATRELLE Style 68MP-420 Saline Round Mod 10888628000254, NATRELLE Style 68MP-450 Saline Round Mod 10888628000261, NATRELLE Style 68MP-480 Saline Round Mod 10888628000278, NATRELLE Style 68MP-510 Saline Round Mod 10888628000285, NATRELLE Style 68MP-550 Saline Round Mod 10888628000292, NATRELLE Style 68MP-600 Saline Round Mod 10888628000308, NATRELLE Style 68MP-650 Saline Round Mod 10888628000315, NATRELLE Style 68MP-700 Saline Round Mod 10888628000322, NATRELLE Style 68MP-750 Saline Round Mod 10888628000339, NATRELLE Style 68MP-800 Saline Round Mod 10888628000346,. Recalled by Allergan PLC.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 25, 2019. Severity: Low. Recall number: Z-0699-2020.

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