Artoura Breast Tissue Expander 700 cc Product Usage: Tissue expanders… — Class II medical device recall Z-2780-2016
Terminated recall by Mentor Texas, LP., reported 2016-09-21, distributed nationwide. The CPX4 Tissue Expander may have been packaged in the Artoura Tissue Expander box.
| Recall number | Z-2780-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mentor Texas, LP., Irving, TX, United States |
| Recall initiated | 2016-08-09 |
| Classified | 2016-09-09 |
| Reported by FDA | 2016-09-21 |
| Terminated | 2017-03-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, DE, GB |
| Quantity | 48 units |
| Lot numbers | 6944785 |
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 for recall
The CPX4 Tissue Expander may have been packaged in the Artoura Tissue Expander box.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2780-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.