Z-2326-2016 Class II Terminated
FDA device recall Z-2326-2016 was initiated by Mentor Texas, LP. on July 1, 2016 and is designated Class II. Reason for recall: The box of 300cc MemoryGel Breast Implant was labeled with null manufacturing and expiration dates. The recall status is terminated (terminated December 9, 2016). Affected quantity: 35 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 10, 2016
- Initiation Date
- July 1, 2016
- Termination Date
- December 9, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 35 units
Product Description
Mentor MemoryGel Breast Implant; Indicated for females for breast augmentation and breast reconstruction.
Reason for Recall
The box of 300cc MemoryGel Breast Implant was labeled with null manufacturing and expiration dates.
Distribution Pattern
Distributed in the states of NY, WI, CA, TX, CO, NC, NJ, OH, TN, RI, and IL.
Code Information
7316994