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.
FDA Recall Z-2781-2016 · Posted 2016-09-10
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Recalling FirmMentor Texas, LP.
Recall StatusTerminated
Product CodeLCJ
Date Initiated2016-08-09
Date Terminated2017-03-08
Product Quantity30 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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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