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Class 1 Device Recall Natrelle Inspira, SiliconeFilled Breast Implants |
 |
| Date Initiated by Firm |
July 24, 2019 |
| Date Posted |
September 11, 2019 |
| Recall Status1 |
Open3, Classified |
| Recall Number |
Z-2453-2019 |
| Recall Event ID |
83500 |
| PMA Number |
P020056 |
| Product Classification |
Prosthesis, breast, noninflatable, internal, silicone gel-filled - Product Code FTR
|
| Product |
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-410,TRL-460,TRL-510,TRL-560,TRL-610;
Style TRLP: TRLP-125TRLP-145,TRLP-165,TRLP-190,TRLP-205,TRLP-220,TRLP-235,TRLP-250,
TRLP-265,TRLP-280,TRLP-300,TRLP-320,TRLP-340,TRLP-360,TRLP-400,TRLP-440,TRLP-490,TRLP-540,TRLP-590,TRLP-640;
Style TRM: TRM-140,TRM-175,TRM-195,TRM-210,TRM-240,TRM-255,TRM-275,TRM-295,TRM-310,TRM-330,TRM-345,TRM-360,TRM-375TRM-405,TRM-445,TRM-485,TRM-520,TRM-560,TRM-600,TRM-640,TRM-685,TRM-755
Style TRF: TRF-180TRF-200,TRF-220,TRF-240,TRF-265,TRF-295,TRF-325,TRF-335,TRF-345,TRF-365,TRF-385,TRF-415,TRF-450,TRF-485,TRF-520,TRF-560,TRF-605,TRF-650,TRF-695,TRF-745,TRF-770;
Style TRX: TRX-205,TRX-225,TRX-255,TRX-285,TRX-310,TRX-340,TRX-375,TRX-400,TRX-420,TRX-445,TRX-470,TRX-495,TRX-525,TRX-545,TRX-560,TRX-580,TRX-615,TRX-650,TRX-700,TRX-750,TRX-800;
Style TSL: TSL-110,
TSL-125,
TSL-140,
TSL-170,
TSL-200,
TSL-230,
TSL-260,
TSL-290,
TSL-320,
TSL-350,
TSL-380,
TSL-410,
TSL-460,
TSL-510,
TSL-560,
TSL-610;
Style TSLP: TSLP-125,
TSLP-145,
TSLP-165,
TSLP-190,
TSLP-205,
TSLP-220,
TSLP-235,
TSLP-250,
TSLP-265,
TSLP-280,
TSLP-300,
TSLP-320,
TSLP-340,
TSLP-360,
TSLP-400,
TSLP-440,
TSLP-490,
TSLP-540,
TSLP-590,
TSLP-640;
Style TSM: TSM-140,
TSM-175,
TSM-195,
TSM-210,
TSM-240,
TSM-255,
TSM-275,
TSM-295,
TSM-310,
TSM-330,
TSM-345,
TSM-360,
TSM-375,
TSM-405,
TSM-445,
TSM-485,
TSM-520,
TSM-560,
TSM-600,
TSM-640,
TSM-685,
TSM-755;
Style TSF: TSF-180
TSF-200
TSF-220
TSF-240
TSF-265
TSF-295
TSF-325
TSF-335
TSF-345
TSF-365
TSF-385
TSF-415
TSF-450
TSF-485
TSF-520
TSF-560
TSF-605
TSF-650
TSF-695
TSF-745
TSF-770
Style TSX: TSX-205,
TSX-225,
TSX-255,
TSX-285,
TSX-310,
TSX-340,
TSX-375,
TSX-400,
TSX-420,
TSX-445,
TSX-470,
TSX-495,
TSX-525,
TSX-545,
TSX-560,
TSX-580,
TSX-615,
TSX-650,
TSX-700,
TSX-750,
TSX-800;
Style TCL: TCL-110,
TCL-125,
TCL-140,
TCL-170,
TCL-200,
TCL-230,
TCL-260,
TCL-290,
TCL-320,
TCL-350,
TCL-380,
TCL-410,
TCL-460,
TCL-510,
TCL-560,
TCL-610;
Style TCLP: TCLP-125,
TCLP-145,
TCLP-165,
TCLP-190,
TCLP-205,
TCLP-220,
TCLP-235,
TCLP-250,
TCLP-265,
TCLP-280,
TCLP-300,
TCLP-320,
TCLP-340,
TCLP-360,
TCLP-400,
TCLP-440,
TCLP-490,
TCLP-540,
TCLP-590,
TCLP-640;
Style TCM: TCM-140,
TCM-175,
TCM-195,
TCM-210,
TCM-240,
TCM-255,
TCM-275
TCM-295
TCM-310,
TCM-330,
TCM-345,
TCM-360,
TCM-375,
TCM-405,
TCM-445,
TCM-485,
TCM-520,
TCM-560,
TCM-600,
TCM-640,
TCM-685,
TCM-755;
Style TCF: TCF-180
TCF-200
TCF-220
TCF-240
TCF-265
TCF-295
TCF-325
TCF-335
TCF-345
TCF-365
TCF-385
TCF-415
TCF-450
TCF-485
TCF-520
TCF-560
TCF-605
TCF-650
TCF-695
TCF-745
TCF-770
Style TCX: TCX-205,
TCX-225,
TCX-255,
TCX-285,
TCX-310,
TCX-340,
TCX-375,
TCX-400
TCX-420,
TCX-445,
TCX-470,
TCX-495,
TCX-525,
TCX-545,
TCX-560,
TCX-580,
TCX-615,
TCX-650,
TCX-700,
TCX-750,
TCX-800;
These products may have been sold under the McGhan, Inamed or NATRELLE brands.
Product Usage: Breast augmentation and Breast reconstruction |
| Code Information |
ALL LOTS Product Code/UDI Style TRL: TRL-125 10888628007659, TRL-140 10888628007666, TRL-170 10888628007673, TRL-200 10888628007680, TRL-230 10888628007697, TRL-260 10888628007703, TRL-290 10888628007710, TRL-320 10888628007727, TRL-350 10888628007734, TRL-380 10888628007741, TRL-410 10888628007758, TRL-460 10888628007765, TRL-510 10888628007772, TRL-560 10888628007789, TRL-610 10888628007796; Style TRLP:TRLP-125 10888628007802, TRLP-145 10888628007819, TRLP-165 10888628007826, TRLP-190 10888628007833, TRLP-205 10888628007840, TRLP-220 10888628007857, TRLP-235 10888628007864, TRLP-250 10888628007871, TRLP-265 10888628007888, TRLP-280 10888628007895, TRLP-300 10888628007901, TRLP-320 10888628007918, TRLP-340 10888628007925, TRLP-360 10888628007932, TRLP-400 10888628007949, TRLP-440 10888628007956, TRLP-490 10888628007963, TRLP-540 10888628007970, TRLP-590 10888628007987, TRLP-640 10888628007994; Style TRM TRM-140 10888628008007, TRM-175 10888628008014, TRM-195 10888628008021, TRM-210 10888628008038, TRM-240 10888628008045, TRM-255 10888628008052, TRM-275 10888628008069, TRM-295 10888628008076, TRM-310 10888628008083, TRM-330 10888628008090, TRM-345 10888628008106, TRM-360 10888628008113, TRM-375 10888628008120, TRM-405 10888628008137, TRM-445 10888628008144, TRM-485 10888628008151, TRM-520 10888628008168, TRM-560 10888628008175, TRM-600 10888628008182, TRM-640 10888628008199, TRM-685 10888628008205, TRM-755 10888628008212; Style TRF: TRF-180 10888628008229, TRF-200 10888628008236, TRF-220 10888628008243, TRF-240 10888628008250, TRF-265 10888628008267, TRF-295 10888628008274, TRF-325 10888628008281, TRF-335 10888628008298, TRF-345 10888628008304, TRF-365 10888628008311, TRF-385 10888628008328, TRF-415 10888628008335, TRF-450 10888628008342, TRF-485 10888628008359, TRF-520 10888628008366, TRF-560 10888628008373, TRF-605 10888628008380, TRF-650 10888628008397, TRF-695 10888628008403, TRF-745 10888628008410, TRF-770 10888628008427; Style TRX: TRX-205 10888628008434, TRX-225 10888628008441, TRX-255 10888628008458, TRX-285 10888628008465, TRX-310 10888628008472, TRX-340 10888628008489, TRX-375 10888628008496, TRX-400 10888628008502, TRX-420 10888628008519, TRX-445 10888628008526, TRX-470 10888628008533, TRX-495 10888628008540, TRX-525 10888628008557, TRX-545 10888628008564, TRX-560 10888628008571, TRX-580 10888628008588, TRX-615 10888628008595, TRX-650 10888628008601, TRX-700 10888628008618, TRX-750 10888628008625, TRX-800 10888628008632; Style TSL: TSL-110 10888628033474, TSL-125 10888628033481, TSL-140 10888628033498, TSL-170 10888628033504, TSL-200 10888628033511, TSL-230 10888628033528, TSL-260 10888628033535, TSL-290 10888628033542, TSL-320 10888628033559, TSL-350 10888628033566, TSL-380 10888628033573, TSL-410 10888628033580, TSL-460 10888628033597, TSL-510 10888628033603, TSL-560 10888628033610, TSL-610 10888628033627; Style TSLP: TSLP-125 10888628033634, TSLP-145 10888628033641, TSLP-165 10888628033658, TSLP-190 10888628033665, TSLP-205 10888628033672, TSLP-220 10888628033689, TSLP-235 10888628033696, TSLP-250 10888628033702, TSLP-265 10888628033719, TSLP-280 10888628033726, TSLP-300 10888628033733, TSLP-320 10888628033740, TSLP-340 10888628033757, TSLP-360 10888628033764 TSLP-400 10888628033771, TSLP-440 10888628033788, TSLP-490 10888628033795, TSLP-540 10888628033801, TSLP-590 10888628033818, TSLP-640 10888628033825; Style TSM: TSM-140 10888628033832, TSM-175 10888628033849, TSM-195 10888628033856, TSM-210 10888628033863, TSM-240 10888628033870, TSM-255 10888628033887, TSM-275 10888628033894, TSM-295 10888628033900, TSM-310 10888628033917, TSM-330 10888628033924, TSM-345 10888628033931, TSM-360 10888628033948, TSM-375 10888628033955, TSM-405 10888628033962, TSM-445 10888628033979, TSM-485 10888628033986, TSM-520 10888628033993, TSM-560 10888628034006, TSM-600 10888628034013, TSM-640 10888628034020, TSM-685 10888628034037, TSM-755 10888628034044; Style TSF: TSF-180 10888628034051, TSF-200 10888628034068, TSF-220 10888628034075, TSF-240 10888628034082, TSF-265 10888628034099, TSF-295 10888628034105, TSF-325 10888628034112, TSF-335 10888628034129, TSF-345 10888628034136, TSF-365 10888628034143, TSF-385 10888628034150, TSF-415 10888628034167, TSF-450 10888628034174, TSF-485 10888628034181, TSF-520 10888628034198, TSF-560 10888628034204, TSF-605 10888628034211, TSF-650 10888628034228, TSF-695 10888628034235, TSF-745 10888628034242, TSF-770 10888628034259; Style TSX: TSX-205 10888628034266, TSX-225 10888628034273, TSX-255 10888628034280, TSX-285 10888628034297, TSX-310 10888628034303, TSX-340 10888628034310, TSX-375 10888628034327, TSX-400 10888628034334, TSX-420 10888628034341, TSX-445 10888628034358, TSX-470 10888628034365, TSX-495 10888628034372, TSX-525 10888628034389, TSX-545 10888628034396, TSX-560 10888628034402, TSX-580 10888628034419, TSX-615 10888628034426, TSX-650 10888628034433, TSX-700 10888628034440, TSX-750 10888628034457, TSX-800 10888628034464; Style TCL: TCL-110 10888628030435, TCL-125 10888628030442, TCL-140 10888628030459, TCL-170 10888628030466, TCL-200 10888628030473, TCL-230 10888628030480, TCL-260 10888628030497, TCL-290 10888628030503, TCL-320 10888628030510, TCL-350 10888628030527, TCL-380 10888628030534, TCL-410 10888628030541, TCL-460 10888628030558, TCL-510 10888628030565, TCL-560 10888628030572, TCL-610 10888628030589; Style TCLP: TCLP-125 10888628030596, TCLP-145 10888628030602, TCLP-165 10888628030619, TCLP-190 10888628030626, TCLP-205 10888628030633, TCLP-220 10888628030640, TCLP-235 10888628030657, TCLP-250 10888628030664, TCLP-265 10888628030671, TCLP-280 10888628030688, TCLP-300 10888628030695, TCLP-320 10888628030701, TCLP-340 10888628030718, TCLP-360 10888628030725, TCLP-400 10888628030732, TCLP-440 10888628030749, TCLP-490 10888628030756, TCLP-540 10888628030763, TCLP-590 10888628030770, TCLP-640 10888628030787; Style TCM: TCM-140 10888628030794, TCM-175 10888628030800, TCM-195 10888628030817, TCM-210 10888628030824, TCM-240 10888628030831, TCM-255 10888628030848, TCM-275 10888628030855, TCM-295 10888628030862, TCM-310 10888628030879, TCM-330 10888628030886, TCM-345 10888628030893, TCM-360 10888628030909 TCM-375 10888628030916, TCM-405 10888628030923, TCM-445 10888628030930, TCM-485 10888628030947, TCM-520 10888628030954, TCM-560 10888628030961, TCM-600 10888628030978, TCM-640 10888628030985, TCM-685 10888628030992, TCM-755 10888628031005; Style TCF: TCF-180 10888628031012, TCF-200 10888628031029, TCF-220 10888628031036, TCF-240 10888628031043, TCF-265 10888628031050, TCF-295 10888628031067, TCF-325 10888628031074, TCF-335 10888628031081, TCF-345 10888628031098, TCF-365 10888628031104, TCF-385 10888628031111, TCF-415 10888628031128, TCF-450 10888628031135, TCF-485 10888628031142, TCF-520 10888628031159, TCF-560 10888628031166, TCF-605 10888628031173, TCF-650 10888628031180, TCF-695 10888628031197, TCF-745 10888628031203, TCF-770 10888628031210; Style TCX: TCX-205 10888628031227, TCX-225 10888628031234, TCX-255 10888628031241, TCX-285 10888628031258, TCX-310 10888628031265, TCX-340 10888628031272, TCX-375 10888628031289, TCX-400 10888628031296, TCX-420 10888628031302, TCX-445 10888628031319, TCX-470 10888628031326, TCX-495 10888628031333, TCX-525 10888628031340, TCX-545 10888628031357, TCX-560 10888628031364, TCX-580 10888628031371, TCX-615 10888628031388, TCX-650 10888628031395, TCX-700 10888628031401, TCX-750 10888628031418, TCX-800 10888628031425 |
Recalling Firm/
Manufacturer |
Allergan PLC
2525 Dupont Dr
Irvine CA 92612-1531
|
| For Additional Information Contact |
Nicole Katz
714-246-4500
|
Manufacturer Reason
for Recall |
The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.
|
FDA Determined
Cause 2 |
Unknown/Undetermined by firm |
| Action |
UPDATE: On June 1, 2020, Allergan issued a press release outlining a dedicated multi-channel campaign to contact women who may not be aware of the Biocell recall and to improve tracking information for U. S. Breast Implant patients (link: https://news.abbvie.com/news/press-releases/allergan-aesthetics-launches-dedicated-multi-channel-campaign-to-contact-patients-who-may-not-be-aware-biocell-recall-and-to-improve-tracking-information-for-us-breast-implant-patients.htm)
On July 24, 2019, Allergan issued a press release related to the recall was posted on the Allergan website (Allergan.com). Recall letters were sent on August 6, 2019 via: FedEx overnight mail with tracking to all consignees who may have product within expiry.
The recall letter will inform customers to do the following:
1. If you have inventory of the recalled products, Quarantine product to prevent its use.
2. Conduct a physical count of the affected products in your possession and record the count on the enclosed Recall Stock Response Form.
3. Send the Recall Stock Response Form to Inmar Rx Solutions, Inc via fax or email within five (5) business days of receipt. To ensure we are able to account for all recalled product, it is imperative that you return the form.
4. Upon receipt of the Response Form, Inmar will issue Return Authorization label(s).
5. When returning the recalled products, attach the prepaid FedEx Authorized Return shipping label to the outside of the return carton and return the recalled product to:
Inmar Rx Solutions, Inc.
4332 Empire Rd. Fort Worth, TX 76155
6. Please Do Not return any products that are not the subject of this recall.
Please contact Inmar Rx Solutions, Inc. if you have any questions about these recall actions.
Patient letters were mailed on August 14, 19 and 26, 2019 to all impacted patients to which Allergan had complete names and addresses in their device tracking database. The patient letters informed customers of the following:
1. How |
| Quantity in Commerce |
4,026,287 Breast Implants and Tissue Expanders Combined in total |
| Distribution |
Worldwide Distribution and US Nationwide
All fifty (50) US States, the US Virgin Islands and Puerto Rico. (AK, AL, AR, AZ, CA, CO, CT, DC, DE, 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, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY).
OUS: Bermuda, Canada, Chile, Japan, Korea, Thailand, Taiwan and Vietnam. |
| Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| PMA Database |
PMAs with Product Code = FTR and Original Applicant = Allergan
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