FDA Device recall Z-2457-2019
Natrelle 133 Tissue Expanders w/Suture Tabs BIOCELL Full Height Variable Projection with MAGNA-FINDEr Xact & 21G Needle Infusion Set STYLE…
- FDA Device
- Class I
- ongoing
- Published 2019-09-18
On 2019-09-18 the FDA classified a Class I recall of Natrelle 133 Tissue Expanders w/Suture Tabs BIOCELL Full Height Variable Projection with MAGNA-FINDEr Xact & 21G Needle Infusion Set STYLE… 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-2457-2019 |
| 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 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-T, 133FV-15-T, 133FV-16-T; STYLE 133MV-T: 133MV-11-T, 133MV-12-T, 133MV-13-T, 133MV-14-T, 133MV-15-T, 133MV-16-T; STYLE 133LV-T: 133LV-11-T, 133LV-12-T, 133LV-13-T, 133LV-14-T, 133LV-15-T, 133LV-16-T; STYLE 133SV-T: 133SV-11-T, 133SV-12-T, 133SV-13-T, 133SV-14-T, 133SV-15-T, 133SV-16-T STYLE 133FX-T: 133FX-11-T, 133FX-12-T, 133FX-13-T, 133FX-14-T, 133FX-15-T, 133FX-16-T; STYLE 133MX-T: 133MX-11-T, 133MX-12-T, 133MX-13-T, 133MX-14-T, 133MX-15-T, 133MX-16-T; STYLE 133SX-T: 133SX-11-T, 133SX-12-T, 133SX-13-T, 133SX-14-T, 133SX-15-T, 133SX-16-T; Product Usage: intended for temporary subcutaneous implantation and require periodic, incremental inflation with sterile saline for injection until the desired amount of tissue is developed.
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 133FV-T: 133FV-11-T 10888628004221, 133FV-12-T 10888628004238, 133FV-13…ALL LOTS; Product Code/UDI STYLE 133FV-T: 133FV-11-T 10888628004221, 133FV-12-T 10888628004238, 133FV-13-T 10888628004245, 133FV-14-T 10888628004252, 133FV-15-T 10888628004269, 133FV-16-T 10888628004276; STYLE 133MV-T: 133MV-11-T 10888628004405, 133MV-12-T 10888628004412, 133MV-13-T 10888628004429, 133MV-14-T 10888628004436, 133MV-15-T 10888628004443, 133MV-16-T 10888628004450; STYLE 133LV-T: 133LV-11-T 10888628004344, 133LV-12-T 10888628004351, 133LV-13-T 10888628004368, 133LV-14-T 10888628004375, 133LV-15-T 10888628004382, 133LV-16-T 10888628004399; STYLE 133FX-T: 133FX-11-T 10888628004283, 133FX-12-T 10888628004290, 133FX-13-T 10888628004306, 133FX-14-T 10888628004313, 133FX-15-T 10888628004320, 133FX-16-T 10888628004337; STYLE 133MX-T: 133MX-11-T 10888628004467, 133MX-12-T 10888628004474, 133MX-13-T 10888628004481, 133MX-14-T 10888628004498, 133MX-15-T 10888628004504, 133MX-16-T 10888628004511; STYLE 133SX-T: 133SX-11-T |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2457-2019%22
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