Mentor Texas, LP.: Tissue expander product mix found: CPX4 350cc was placed in a carton for the CPX4 450cc

Agency Publication Date: September 7, 2016

Affected Products

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.

Lot 6981537

Lot Numbers:

6981537

Product: 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.

Lot 6981543

Lot Numbers:

6981543

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 74895

Status: Resolved

Manufacturer: Mentor Texas, LP.

Manufactured In: United States

Units Affected: 2 products (65 units; 70 units)

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Sources: FDA iRES · Raw API Response

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Affected Products

Lot 6981537

Lot Numbers:

6981537

Lot 6981543

Lot Numbers:

6981543