FDA Device recall Z-2454-2019
Natrelle and McGhan Silicone-Filled Breast Implant BioCell Round Moderate Profile, Sterile, for the following style numbers: Style 110:110-…
- FDA Device
- Class I
- ongoing
- Published 2019-09-18
On 2019-09-18 the FDA classified a Class I recall of Natrelle and McGhan Silicone-Filled Breast Implant BioCell Round Moderate Profile, Sterile, for the following style numbers: Style 110:110-… by Allergan, citing 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 lymph….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2454-2019 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2019-07-24 |
| Published | 2019-09-18 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Allergan |
| Distribution | US |
Product
Natrelle and McGhan Silicone-Filled Breast Implant BioCell Round Moderate Profile, Sterile, for the following style numbers: Style 110:110-090, 110-120, 110-150, 110-180, 110-210, 110-240, 110-270, 110-300, 110-330, 110-360, 110-390, 110-420, 110-450, 110-480, 110-510; Style 115 :115-150, 115-167, 115-185, 115-203, 115-222, 115-253, 115-272, 115-290, 115-322, 115-354, 115-378, 115-401, 115-435, 115-469, 115-507, 115-547, 115-586, 115-627, 115-666, 115-716; Style 120: 120-180, 120-220, 120-260, 120-300, 120-340, 120-400, 120-440, 120-500, 120-550, 120-600, 120-650; These products may have been sold under the McGhan, Inamed or NATRELLE brands. Product Usage: Breast augmentation and Breast reconstruction
Reason
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.
Identifiers
| code_info | ALL LOTS Product Code/UDI STYLE 110:110-090 10888628002159, 110-120 10888628002166, 110-150 10888628002173, 1…ALL LOTS Product Code/UDI STYLE 110:110-090 10888628002159, 110-120 10888628002166, 110-150 10888628002173, 110-180 10888628002180, 110-210 10888628002197, 110-240 10888628002203, 110-270 10888628002210, 110-300 10888628002227, 110-330 10888628002234, 110-360 10888628002241, 110-390 10888628002258, 110-420 10888628002265, 110-450 10888628002272, 110-480 10888628002289, 110-510 10888628002296; STYLE 115:115-150 10888628002302, 115-167 10888628002319, 115-185 10888628002326, 115-203 10888628002333, 115-222 10888628002340, 115-253 10888628002357, 115-272 10888628002364, 115-290 10888628002371, 115-322 10888628002388, 115-354 10888628002395, 115-378 10888628002401, 115-401 10888628002418, 115-435 10888628002425, 115-469 10888628002432, 115-507 10888628002449, 115-547 10888628002456, 115-586 10888628002463, 115-627 10888628002470, 115-666 10888628002487, 115-716 10888628002494; STYLE 120:120-180 10888628002500, 120-220 10888628002517, 120-260 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2454-2019%22
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