FDA Device recall Z-2455-2019
Natrelle 133 Tissue Expanders (also named style 133 BIOSPAN Tissue Expander and Mcghan Magna-Site Tissue Expander) BioCell Full Height Vari…
- 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 (also named style 133 BIOSPAN Tissue Expander and Mcghan Magna-Site Tissue Expander) BioCell Full Height Vari… 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-2455-2019 |
| 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 (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 Set, Sterile, for the following style numbers: STYLE 133FV: 133FV-11, 133FV-12, 133FV-13, 133FV-14, 133FV-15, 133FV-16; STYLE 133MV: 133MV-11, 133MV-12, 133MV-13, 133MV-14, 133MV-15, 133MV-16; STYLE 133LV: 133LV-11, 133LV-12, 133LV-13, 133LV-14, 133LV-15, 133LV-16; STYLE 133FX: 133FX-11 133FX-12 133FX-13 133FX-14 133FX-15 133FX-16 STYLE 133MX: 133MX-11, 133MX-12, 133MX-13, 133MX-14, 133MX-15, 133MX-16; STYLE 133SX: 133SX-11, 133SX-12, 133SX-13, 133SX-14, 133SX-15, 133SX-16; STYLE 133SV: 133SV-11, 133SV-12, 133SV-13, 133SV-14, 133SV-15, 133SV-16; 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 133FV: 133FV-11 10888628003927, 133FV-12 10888628003934, 133FV-13 10888…ALL LOTS Product Code/UDI STYLE 133FV: 133FV-11 10888628003927, 133FV-12 10888628003934, 133FV-13 10888628003941, 133FV-14 10888628003958, 133FV-15 10888628003965, 133FV-16 10888628003972; STYLE 133MV: 133MV-11 10888628004108, 133MV-12 10888628004115, 133MV-13 10888628004122, 133MV-14 10888628004139, 133MV-15 10888628004146, 133MV-16 10888628004153; STYLE 133LV: 133LV-11 10888628004047, 133LV-12 10888628004054, 133LV-13 10888628004061, 133LV-14 10888628004078, 133LV-15 10888628004085, 133LV-16 10888628004092; STYLE 133FX: 133FX-11 10888628003989, 133FX-12 10888628003996, 133FX-13 10888628004009, 133FX-14 10888628004016, 133FX-15 10888628004023, 133FX-16 10888628004030; STYLE 133MX: 133MX-11 10888628004160, 133MX-12 10888628004177, 133MX-13 10888628004184, 133MX-14 10888628004191, 133MX-15 10888628004207, 133MX-16 10888628004214; STYLE 133SX: 133SX-11 10888628003804, 133SX-12 10888628003811, 133SX-13 10888628003828, 133SX-1 |
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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-2455-2019%22
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