Z-2748-2016 Class II Terminated
FDA device recall Z-2748-2016 was initiated by Mentor Texas, LP. on August 9, 2016 and is designated Class II. Reason for recall: Tissue expander product mix found: CPX4 350cc was placed in a carton for the CPX4 450cc The recall status is terminated (terminated March 8, 2017). Affected quantity: 70 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 14, 2016
- Initiation Date
- August 9, 2016
- Termination Date
- March 8, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 70 units
Product Description
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.
Reason for Recall
Tissue expander product mix found: CPX4 350cc was placed in a carton for the CPX4 450cc
Distribution Pattern
Worldwide Distribution: US (nationwide) and countries of: South Korea, Argentina, Mexico, Canada, Australia and New Zealand.
Code Information
Lot 6981543