CLASS II Device recall · Reported 21 Sep 2016 · FDA Enforcement Report
CPX4 Breast Tissue Expander 650 cc recalled by Mentor Texas, LP
Mentor Texas, LP is recalling CPX4 Breast Tissue Expander 650 cc, distributed nationwide in the US. The recall was initiated on 9 Aug 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2781-2016
- FDA event ID
- 74899
- Recalling firm
- Mentor Texas, LP, Irving, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Aug 2016
- FDA classified
- 9 Sep 2016
- Reported
- 21 Sep 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- E. coli
- Device type
- Breast Implants
Timeline
| 9 Aug 2016 | Recall initiated by company | |
| 9 Sep 2016 | Classified by FDA | +31 days |
| 21 Sep 2016 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The CPX4 Tissue Expander may have been packaged in the Artoura Tissue Expander box.
Some strains of E. coli, such as O157:H7, produce a toxin that can cause severe stomach cramps, bloody diarrhea and, in a small number of cases, kidney failure.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution - US Nationwide and the countries of: Germany, UK, and Belgium
Questions about this recall
Is CPX4 Breast Tissue Expander 650 cc recalled?
Yes. Mentor Texas, LP recalled CPX4 Breast Tissue Expander 650 cc on 9 Aug 2016. The recall is Class II and its status is Terminated. Recall number Z-2781-2016.
Why was it recalled?
The CPX4 Tissue Expander may have been packaged in the Artoura Tissue Expander box.
Which lots are affected?
Lot 6947019
Where was it sold?
Worldwide Distribution - US Nationwide and the countries of: Germany, UK, and Belgium
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Mentor Texas, LP
All 16| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Artoura Breast Tissue Expanders Reference Numbers recalled | Mentor Texas, LP | Device Malfunction | Nationwide |
| Device | CLASS II | CPX 4 US Breast Tissue Expanders recalled by Mentor Texas, LP | Mentor Texas, LP | Device Malfunction | Nationwide |
| Device | CLASS II | Artoura Breast Tissue Expanders Reference Numbers recalled | Mentor Texas, LP | Device Malfunction | Nationwide |
| Device | CLASS II | CPX 4 US Breast Tissue Expanders recalled by Mentor Texas, LP | Mentor Texas, LP | Device Malfunction | Nationwide |
| Device | CLASS II | CPX 4 US Breast Tissue Expanders recalled by Mentor Texas, LP | Mentor Texas, LP | Device Malfunction | Nationwide |
Other Breast Implants recalls
All 29| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Artoura Breast Tissue Expanders Reference Numbers recalled | Mentor Texas, LP | Device Malfunction | Nationwide |
| Device | CLASS II | Artoura Breast Tissue Expanders Reference Numbers recalled | Mentor Texas, LP | Device Malfunction | Nationwide |
| Device | CLASS II | Artoura Breast Tissue Expanders Reference Numbers recalled | Mentor Texas, LP | Device Malfunction | Nationwide |
| Device | CLASS II | B. Braun BBraun Medical Winged INF recalled | B Braun Medical | Device Malfunction | Nationwide |
| Device | CLASS II | B. Braun Winged Infusion, Single PK recalled by B Braun Medical | B Braun Medical | Device Malfunction | Nationwide |