Recall Z-2747-2016
Mentor Texas, LP. · initiated August 9, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Lot 6981537
Reason for recall
Tissue expander product mix found: CPX4 350cc was placed in a carton for the CPX4 450cc
FDA-determined cause: Employee error
Action taken
The firm, Mentor, sent an "MEDICAL DEVICE REMOVAL" letter dated 8/11/2016 to affected consignees. The letter will be followed up with a respective sales representative visit. The letter described the product, problem and actions to be taken. The consignees were instructed to immediately identify all unused units and return them per the normal return process; forward the letter to anyone your facility that needs to be informed; if you have sent these units to another facility, forward the letter to that facility; and maintain awareness of the letter until all units in your inventory have been returned. If you have any questions, please contact your local Mentor sales representative or Mentor Customer Service at 1-800-235-5731.
Details
- Recall number
- Z-2747-2016
- Initiated
- August 9, 2016
- Posted by FDA
- September 7, 2016
- Terminated
- March 8, 2017
- Product code
- LCJ – Tissue Expander And Accessories
- Quantity
- 65 units
- Distribution
- Worldwide Distribution: US (nationwide) and countries of: South Korea, Argentina, Mexico, Canada, Australia and New Zealand.
- Recalling firm
- Mentor Texas, LP., Irving, TX
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2748-2016 Class II | MENTOR 2" Tall Height TE With Sutures 450cc PN: 354-9313 The MENTOR CPX4 and CPX4 with…Tissue expander product mix found: CPX4 350cc was placed in a carton for the CPX4 450cc | 08/09/2016Terminated |