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

Recall Z-2780-2016 — 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 a

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-2780-2016
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: The CPX4 Tissue Expander may have been packaged in the Artoura Tissue Expander box.

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

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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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