CPX4 Breast Tissue Expander 650 cc recallZ-2781-2016 · Mentor Texas, LP. · initiated Aug 9, 2016
Class II Terminated All recalls posted in September 2016
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Mentor Texas, LP. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The CPX4 Tissue Expander may have been packaged in the Artoura Tissue Expander box.
FDA root cause category: Employee error
What the company is doing
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 .
Recall details
- Recall number
- Z-2781-2016
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Aug 9, 2016
- Posted by the FDA
- Sep 10, 2016
- Recalling firm
- Mentor Texas, LP.
- Quantity
- 30 units
- Product code
- LCJ
- FDA submissions
- K130813
- Distribution
- Worldwide Distribution - US Nationwide and the countries of: Germany, UK, and Belgium
Product description
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.
Code information (models, lots, serial numbers)
Lot 6947019
Other devices under the same FDA submission
34 devices cleared under K130813 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- MENTOR CPX 4 Breast Tissue Expander with Suture Tabs 3549314Mentor Texas L.P. · EXPANDER, SKIN, INFLATABLE1 recall22 reports
- MENTOR CPX 4 Breast Tissue Expander with Suture Tabs 3549113Mentor Texas L.P. · EXPANDER, SKIN, INFLATABLE1 recall7 reports
- MENTOR CPX 4 Breast Tissue Expander with Suture Tabs 3549214Mentor Texas L.P. · EXPANDER, SKIN, INFLATABLE57 reports
- MENTOR CPX 4 Breast Tissue Expander with Suture Tabs 3549213Mentor Texas L.P. · EXPANDER, SKIN, INFLATABLE52 reports
- MENTOR CPX 4 Breast Tissue Expander with Suture Tabs 3549215Mentor Texas L.P. · EXPANDER, SKIN, INFLATABLE34 reports
- MENTOR CPX 4 Breast Tissue Expander 3548213Mentor Texas L.P. · EXPANDER, SKIN, INFLATABLE22 reports
- MENTOR CPX 4 Breast Tissue Expander with Suture Tabs 3549212Mentor Texas L.P. · EXPANDER, SKIN, INFLATABLE21 reports
- MENTOR CPX 4 Breast Tissue Expander 3548214Mentor Texas L.P. · EXPANDER, SKIN, INFLATABLE20 reports
- MENTOR CPX 4 Breast Tissue Expander with Suture Tabs 3549216Mentor Texas L.P. · EXPANDER, SKIN, INFLATABLE19 reports
- MENTOR CPX 4 Breast Tissue Expander with Suture Tabs 3549313Mentor Texas L.P. · EXPANDER, SKIN, INFLATABLE19 reports
- MENTOR CPX 4 Breast Tissue Expander with Suture Tabs 3549315Mentor Texas L.P. · EXPANDER, SKIN, INFLATABLE15 reports
- MENTOR CPX 4 Breast Tissue Expander 3548215Mentor Texas L.P. · EXPANDER, SKIN, INFLATABLE12 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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