MENTOR 2" Tall Height TE With Sutures 350cc PN: 354-9312 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.
Reported: September 14, 2016 Initiated: August 9, 2016 #Z-2747-2016
Product Description
MENTOR 2" Tall Height TE With Sutures 350cc PN: 354-9312 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.
Reason for Recall
Tissue expander product mix found: CPX4 350cc was placed in a carton for the CPX4 450cc
Details
- Recalling Firm
- Mentor Texas, LP.
- Units Affected
- 65 units
- Distribution
- Worldwide Distribution: US (nationwide) and countries of: South Korea, Argentina, Mexico, Canada, Australia and New Zealand.
- Location
- Irving, TX
Frequently Asked Questions
What product was recalled? ▼
MENTOR 2" Tall Height TE With Sutures 350cc PN: 354-9312 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.. Recalled by Mentor Texas, LP.. Units affected: 65 units.
Why was this product recalled? ▼
Tissue expander product mix found: CPX4 350cc was placed in a carton for the CPX4 450cc
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 14, 2016. Severity: Moderate. Recall number: Z-2747-2016.
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