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.

Recall Insight

This FDA Devices action (record #Z-2781-2016) was formally reported on September 21, 2016, with the manufacturer initiating the action on August 9, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Mentor Texas, LP. is listed as the recalling firm, operating out of Irving, TX. Federal records indicate 30 units units are affected.

The documented reason for this recall is: The CPX4 Tissue Expander may have been packaged in the Artoura Tissue Expander box. Distribution data in the federal record shows the product reached: Worldwide Distribution - US Nationwide and the countries of: Germany, UK, and Belgium. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 10 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.