Class II — Mentor Texas, LP.
| Recalling firm | MENTOR Texas, LP |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The CPX4 Tissue Expander may have been packaged in the Artoura Tissue Expander box. |
| 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. |
| Quantity | 48 units |
| Distribution | Worldwide Distribution - US Nationwide and the countries of: Germany, UK, and Belgium |
| Initiated | 2016-08-09 |
| Classified | 2016-09-09 |
| Terminated | 2017-03-08 |
| Recall number | Z-2780-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Mentor Texas, LP. (Z-2780-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/74899/
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