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Terminated

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.

FDA Recall Z-2780-2016 · Posted 2016-09-10

Recalling FirmMentor Texas, LP.
Recall StatusTerminated
Product CodeLCJ
Date Initiated2016-08-09
Date Terminated2017-03-08
Product Quantity48 units

Reason for Recall

The CPX4 Tissue Expander may have been packaged in the Artoura Tissue Expander box.

Firm Action

Mentor Texas sent an Urgent Field Safety Notice dated August 11, 2016 to customers.via letter and a follow-up with respective Sales Representative visit. The letter identified the affected product, problems and actions to be taken. Customers were informed the firm will credit/replace returned affected products. For questions contact your Sales Representative .

Root Cause

Employee error

Distribution Pattern

Worldwide Distribution - US Nationwide and the countries of: Germany, UK, and Belgium

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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