Recall Z-2326-2016
Mentor Texas, LP. · initiated July 1, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Mentor MemoryGel Breast Implant; Indicated for females for breast augmentation and breast reconstruction.
Codes / lots: 7316994
Reason for recall
The box of 300cc MemoryGel Breast Implant was labeled with null manufacturing and expiration dates.
FDA-determined cause: Labeling mix-ups
Action taken
The affected consignees were notified via customer letter on 7/1/16, and a follow-up with respective sales representative via visit.
Details
- Recall number
- Z-2326-2016
- Initiated
- July 1, 2016
- Terminated
- December 9, 2016
- Product code
- FTR – Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
- Quantity
- 35 units
- Distribution
- Distributed in the states of NY, WI, CA, TX, CO, NC, NJ, OH, TN, RI, and IL.
- Recalling firm
- Mentor Texas, LP., Irving, TX