FDA Device recall Z-2780-2016
Artoura Breast Tissue Expander 700 cc Product Usage: Tissue expanders can be used for breast reconstruction after mastectomy, correction of…
- FDA Device
- Class II
- terminated
- Published 2016-09-21
On 2016-09-21 the FDA classified a Class II recall of Artoura Breast Tissue Expander 700 cc Product Usage: Tissue expanders can be used for breast reconstruction after mastectomy, correction of… by Mentor Texas, citing the CPX4 Tissue Expander may have been packaged in the Artoura Tissue Expander box.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2780-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-08-09 |
| Published | 2016-09-21 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Mentor Texas |
| Distribution | US |
Product
Artoura Breast Tissue Expander 700 cc Product Usage: Tissue expanders can be used for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision and tissue defect procedures. The devices are intended for temporary subcutaneous or sub muscular implantation and are not intended for use beyond six months.
Reason
The CPX4 Tissue Expander may have been packaged in the Artoura Tissue Expander box.
Identifiers
| code_info | Lot 6944785 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2780-2016%22
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