CLASS II Device recall · Reported 14 Sep 2016 · FDA Enforcement Report
Mentor 2" Tall Height TE With Sutures 450cc PN recalled
Mentor Texas is recalling Mentor 2" Tall Height TE With Sutures 450cc PN: 354-9313 The Mentor CPX4 and CPX4 with, 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-2748-2016
- FDA event ID
- 74895
- Recalling firm
- Mentor Texas, Irving, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Aug 2016
- FDA classified
- 7 Sep 2016
- Reported
- 14 Sep 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- E. coli
- Device type
- Surgical Instruments
Timeline
| 9 Aug 2016 | Recall initiated by company | |
| 7 Sep 2016 | Classified by FDA | +29 days |
| 14 Sep 2016 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Tissue expander product mix found: CPX4 350cc was placed in a carton for the CPX4 450cc
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
MENTOR 2" Tall Height TE With Sutures 450cc PN: 354-9313 The MENTOR CPX4 and CPX4 with Suture Tabs Breast Tissue Expanders are used for breast reconstruction following mastectomy and are intended for temporary subcutaneous or submuscular implantation and are not intended for use beyond six months.
Where it was distributed
Worldwide Distribution: US (nationwide) and countries of: South Korea, Argentina, Mexico, Canada, Australia and New Zealand.
Questions about this recall
Why was it recalled?
Tissue expander product mix found: CPX4 350cc was placed in a carton for the CPX4 450cc
Which lots are affected?
Lot 6981543
Where was it sold?
Worldwide Distribution: US (nationwide) and countries of: South Korea, Argentina, Mexico, Canada, Australia and New Zealand.
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 74895| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Mentor 2" Tall Height TE With Sutures 350cc PN recalled | Mentor Texas | E. coli | Nationwide |
More recalls from Mentor Texas
All 17| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Syringe Luer Lok 10cc-200/box Bd recalled by Mentor Texas | Mentor Texas | Device Malfunction | CA, FL, PA |
| Device | CLASS II | Artoura Breast Tissue Expanders Reference Numbers recalled | Mentor Texas | Device Malfunction | Nationwide |
| Device | CLASS II | CPX 4 US Breast Tissue Expanders recalled by Mentor Texas, LP | Mentor Texas | Device Malfunction | Nationwide |
| Device | CLASS II | Artoura Breast Tissue Expanders Reference Numbers recalled | Mentor Texas | Device Malfunction | Nationwide |
| Device | CLASS II | CPX 4 US Breast Tissue Expanders recalled by Mentor Texas, LP | Mentor Texas | Device Malfunction | Nationwide |
Other Surgical Instruments recalls
All 3,883| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Hopkins Telescope 30¿ recalled by Karl Storz Endoscopy | Karl Storz Endoscopy | Packaging Defects | Nationwide |
| Device | CLASS II | Disposable Tourniquet Cuff, 24" X 4" 1-Line, Yellow recalled | ASP Global | Device Malfunction | Nationwide |
| Device | CLASS II | Mpr Single Use Tourniquet Cuff 15" 1 Line recalled by ASP Global | ASP Global | Device Malfunction | Nationwide |
| Device | CLASS II | Expressaire Disposable Tourniquet Cuff, 12" X 3.5" 1-Line (CS Plum recalled | ASP Global | Device Malfunction | Nationwide |
| Device | CLASS II | Disposable Tourniquet Cuff, 44" X 4" 2-Line, Green recalled | ASP Global | Device Malfunction | Nationwide |