FDA Device recall Z-2456-2019
Natrelle133 Plus Tissue Expander With/Without Suture Tabs, BioCell Full Height Variable Projection with Magna-Fider Xact & 21G Needle Infus…
- FDA Device
- Class I
- ongoing
- Published 2019-09-18
On 2019-09-18 the FDA classified a Class I recall of Natrelle133 Plus Tissue Expander With/Without Suture Tabs, BioCell Full Height Variable Projection with Magna-Fider Xact & 21G Needle Infus… 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-2456-2019 |
| 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
Natrelle133 Plus Tissue Expander With/Without Suture Tabs, BioCell Full Height Variable Projection with Magna-Fider Xact & 21G Needle Infusion Set, Sterile, for the following style numbers: STYLE 133P-FV: 133P-FV-11, 133P-FV-12, 133P-FV-13, 133P-FV-14, 133P-FV-15, 133P-FV-16; STYLE 133P-MV: 133P-MV-11, 133P-MV-12, 133P-MV-13, 133P-MV-14, 133P-MV-15, 133P-MV-16; STYLE 133P-LV: 133P-LV-11, 133P-LV-12, 133P-LV-13, 133P-LV-14, 133P-LV-15, 133P-LV-16; STYLE 133P-FX: 133P-FX-11, 133P-FX-12, 133P-FX-13, 133P-FX-14, 133P-FX-15, 133P-FX-16; STYLE 133P-MX:133P-MX-11,133P-MX-12, 133P-MX-13, 133P-MX-14, 133P-MX-15, 133P-MX-16; STYLE 133P-SX: 133P-SX-11, 133P-SX-12, 133P-SX-13, 133P-SX-14, 133P-SX-15, 133P-SX-16; STYLE 133P-SV: 133P-SV-11,133P-SV-12, 133P-SV-13, 133P-SV-14, 133P-SV-15, 133P-SV-16; STYLE 133P-FV-T:133P-FV-11-T, 133P-FV-12-T, 133P-FV-13-T, 133P-FV-14-T, 133P-FV-15-T, 133P-FV-16-T; STYLE 133P-MV-T: 133P-MV-11-T, 133P-MV-12-T, 133P-MV-13-T, 133P-MV-14-T, 133P-MV-15-T, 133P-MV-16-T; STYLE 133P-LV-T: 133P-LV-11-T, 133P-LV-12-T, 133P-LV-13-T, 133P-LV-14-T, 133P-LV-15-T, 133P-LV-16-T; STYLE 133P-FX-T: 133P-FX-11-T, 133P-FX-12-T, 133P-FX-13-T, 133P-FX-14-T, 133P-FX-15-T, 133P-FX-16-T; STYLE 133P-MX-T: 133P-MX-11-T, 133P-MX-12-T, 133P-MX-13-T, 133P-MX-14-T, 133P-MX-15-T, 133P-MX-16-T; STYLE 133P-SX-T: 133P-SX-11-T, 133P-SX-12-T, 133P-SX-13-T, 133P-SX-14-T, 133P-SX-15-T, 133P-SX-16-T; STYLE 133P-SV-T: 133P-SV-11-T, 133P-SV-12-T, 133P-SV-13-T, 133P-SV-14-T, 133P-SV-15-T, 133P-SV-16-T These products may have been sold under the McGhan, Inamed or NATRELLE brands. 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 133P-FV:133P-FV-11 10888628009646, 133P-FV-11-T 10888628009653, 133P-FV-12…ALL LOTS; Product Code/UDI STYLE 133P-FV:133P-FV-11 10888628009646, 133P-FV-11-T 10888628009653, 133P-FV-12 10888628009660, 133P-FV-12-T 10888628009677, 133P-FV-13 10888628009684, 133P-FV-13-T 10888628009691, 133P-FV-14 10888628009707, 133P-FV-14-T 10888628009714, 133P-FV-15 10888628009721, 133P-FV-15-T 10888628009738, 133P-FV-16 10888628009745; STYLE 133P-MV: 133P-MV-11 10888628010000, 133P-MV-12 10888628010024, 133P-MV-13 10888628010048, 133P-MV-14 10888628010062, 133P-MV-15 10888628010086, 133P-MV-16 10888628010109; STYLE 133P-LV: 133P-LV-11 10888628009882, 133P-LV-12 10888628009905, 133P-LV-13 10888628009929, 133P-LV-14 10888628009943, 133P-LV-15 10888628009967, 133P-LV-16 10888628009981; STYLE 133P-FX: 133P-FX-11 10888628009769, 133P-FX-12 10888628009783, 133P-FX-13 10888628009806, 133P-FX-14 10888628009820, 133P-FX-15 10888628009844, 133P-FX-16 10888628009868; STYLE 133P-MX: 133P-MX-11 10888628010123, 133P-MX-12 10888628010147, |
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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-2456-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.