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Product Description
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Recall Class
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FDA Recall Posting Date
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Recalling Firm
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Z-2463-2019 - Komuro, Soft Touch, BIOCELL, INTRASHIEL, BioDIMENSIONAL breast implants, Styles KML, KMM, KLL, KLM
Product Usage: Breast augmentation and Breast reconstruction
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1
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09/11/2019
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Allergan PLC
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Z-2459-2019 - McGhan BioDIMENSIONAL silicone-Filled Breast Implants, style 153
Product Usage: Breast augmentation and Breast reconstruction
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1
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09/11/2019
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Allergan PLC
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Z-2458-2019 - McGhan Croissant-Shaped Tissue Expanders, Style 134
Product Usage: intended for temporary subcutaneous implantation and require periodic, incremental inflation with sterile saline for injection un...
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1
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09/11/2019
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Allergan PLC
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Z-2455-2019 - Natrelle 133 Tissue Expanders (also named style 133 BIOSPAN Tissue Expander and Mcghan Magna-Site Tissue Expander) BioCell Full Height Variable Projection with Magna-Fider Xact & 21G Needle Infusion S...
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1
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09/11/2019
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Allergan PLC
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Z-2457-2019 - Natrelle 133 Tissue Expanders w/Suture Tabs BIOCELL Full Height Variable Projection with MAGNA-FINDEr Xact & 21G Needle Infusion Set
STYLE 133FV-T:
133FV-11-T,
133FV-12-T,
133FV-13-T,
133FV-14-...
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1
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09/11/2019
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Allergan PLC
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Z-2465-2019 - Natrelle 150 Full Height and Short Height Implants, BIOCELL, INTRASHIEL, BioDIMENSIONAL Breast Implant, Styles 150 FH and 150 SH.
Product Usage: Breast augmentation and Breast reconstruction
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1
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09/11/2019
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Allergan PLC
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Z-2452-2019 - Natrelle 410, Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implant Biocell Low Height Low Projection, Sterile, for the following style numbers:
Syle LL: LL-410135,LL-410180,LL-410210,...
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1
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09/11/2019
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Allergan PLC
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Z-2461-2019 - Natrelle 510, TruForm, Dual-Gel, BIOCELL, Styles LX, MX, FX
Product Usage: Breast augmentation and Breast reconstruction
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1
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09/11/2019
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Allergan PLC
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Z-2453-2019 - Natrelle Inspira, Silicone-Filled Breast Implants, Sterile, for the following style numbers:
Style TRL: TRL-110TRL-125,TRL-140,TRL-170,TRL-200,TRL-230,TRL-260,TRL-290,TRL-320,TRL-350,TRL-380,TRL-41...
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1
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09/11/2019
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Allergan PLC
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Z-2460-2019 - Natrelle and McGhan 410 TruForm 2 (Soft Touch) BIOCELL breast implant, Styles LL, LM, LF, ML, MM, MF, FL, FM, FF
Product Usage: Breast augmentation and Breast reconstruction
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1
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09/11/2019
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Allergan PLC
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