MENTOR 2" Tall Height TE With Sutures 350cc PN: 354-9312 The MENTOR… — Class II medical device recall Z-2747-2016
Terminated recall by Mentor Texas, LP., reported 2016-09-14, distributed nationwide. Tissue expander product mix found: CPX4 350cc was placed in a carton for the CPX4 450cc
| Recall number | Z-2747-2016 |
|---|---|
| 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 | 2016-09-07 |
| Reported by FDA | 2016-09-14 |
| Terminated | 2017-03-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, CA, KR, MX, NZ |
| Quantity | 65 units |
| Lot numbers | 6981537 |
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 for recall
Tissue expander product mix found: CPX4 350cc was placed in a carton for the CPX4 450cc
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-2747-2016. 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.