Device product
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.
Z-2747-2016
Product summary
- Event
- Event 74895
- Status
- Terminated
- Classification
- Class II
- Quantity
- 65 units
- Official record key
device-enforcement:Z-2747-2016
Official wording
Reason: Tissue expander product mix found: CPX4 350cc was placed in a carton for the CPX4 450cc
Code information: Lot 6981537
Distribution pattern: Worldwide Distribution: US (nationwide) and countries of: South Korea, Argentina, Mexico, Canada, Australia and New Zealand.
Derived failure modes
-
Unknown
Tissue expander product mix found: CPX4 350cc was placed in a carton for the CPX4 450cc