FDA Device recall Z-2781-2016
CPX4 Breast Tissue Expander 650 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 CPX4 Breast Tissue Expander 650 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-2781-2016 |
| 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
CPX4 Breast Tissue Expander 650 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 6947019 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Other recalls by Mentor Texas
- SYRINGE LUER LOK 10CC-200/BOX BD Product Code: 302995 Mentor Product Code: B9604 Syringe, Piston
FDA Device · Class II · 2026-07-08 · Mentor Texas - Artoura Breast Tissue Expanders Reference Numbers: TEXP110RH TEXP120RH TEXP120RUH TEXP130RH TEXP135RH TEXP140RH TEXP150RH Textured, High &…
FDA Device · Class II · 2026-04-08 · Mentor Texas - CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-157LH Smooth Low Height Tissue Expander, 650cc
FDA Device · Class II · 2026-04-08 · Mentor Texas - CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-113TH, SCPX-123TH, SCPX-140TH, SCPX-146TH Smooth Tall Height Tiss…
FDA Device · Class II · 2026-04-08 · Mentor Texas - Artoura Breast Tissue Expanders Reference Numbers: SDC-100H SDC-110H SDC-120H SDC-130H SDC-135H SDC-140H SDC-150H SDC-155H Smooth High Prof…
FDA Device · Class II · 2026-04-08 · Mentor Texas
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2781-2016%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.