FDA Device recall Z-2747-2016
MENTOR 2" Tall Height TE With Sutures 350cc PN: 354-9312 The MENTOR CPX4 and CPX4 with Suture Tabs Breast Tissue Expanders are used for bre…
- FDA Device
- Class II
- terminated
- Published 2016-09-14
On 2016-09-14 the FDA classified a Class II recall of MENTOR 2" Tall Height TE With Sutures 350cc PN: 354-9312 The MENTOR CPX4 and CPX4 with Suture Tabs Breast Tissue Expanders are used for bre… by Mentor Texas, citing tissue expander product mix found: CPX4 350cc was placed in a carton for the CPX4 450cc.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2747-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-08-09 |
| Published | 2016-09-14 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Mentor Texas |
| Distribution | US |
Product
MENTOR 2" Tall Height TE With Sutures 350cc PN: 354-9312 The MENTOR CPX4 and CPX4 with Suture Tabs Breast Tissue Expanders are used for breast reconstruction following mastectomy and are intended for temporary subcutaneous or submuscular implantation and are not intended for use beyond six months.
Reason
Tissue expander product mix found: CPX4 350cc was placed in a carton for the CPX4 450cc
Identifiers
| code_info | Lot 6981537 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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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-2747-2016%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.