Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2748-2016 — MENTOR 2" Tall Height TE With Sutures 450cc PN: 354-9313 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

U.S. FDA — Device Enforcement · United States · 2016-08-09 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2748-2016
Date of alert: 2016-08-09
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Mentor Texas, LP.
Product category: device
Product type: Devices

Reported risk: Tissue expander product mix found: CPX4 350cc was placed in a carton for the CPX4 450cc

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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