Mentor Texas, LP.: The CPX4 Tissue Expander may have been packaged in the Artoura Tissue Expander box.

Agency Publication Date: September 10, 2016

Affected Products

Product: 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 are not intended for use beyond six months.

Lot 6944785

Lot Numbers:

6944785

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.

Lot 6947019

Lot Numbers:

6947019

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 74899

Status: Resolved

Manufacturer: Mentor Texas, LP.

Manufactured In: United States

Units Affected: 2 products (48 units; 30 units)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

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Affected Products

Lot 6944785

Lot Numbers:

6944785

Lot 6947019

Lot Numbers:

6947019