FDA Medical Device Recalls (openFDA)
Mentor Texas, LP.: Mentor MemoryGel Breast Implant; Indicated for females for breast augmentation and breast reconstruction.
- Recall number
- Z-2326-2016
- Recalling firm
- Mentor Texas, LP.
- Product
- Mentor MemoryGel Breast Implant; Indicated for females for breast augmentation and breast reconstruction.
- Status
- Terminated
- Initiated
- 2016-07-01
- Posted
- not on file
- Terminated
- 2016-12-09
- Reason
- The box of 300cc MemoryGel Breast Implant was labeled with null manufacturing and expiration dates.
- Root cause
- Labeling mix-ups
- Action
- The affected consignees were notified via customer letter on 7/1/16, and a follow-up with respective sales representative via visit.
- Quantity
- 35 units
- Distribution
- Distributed in the states of NY, WI, CA, TX, CO, NC, NJ, OH, TN, RI, and IL.
- Lot, serial or model codes
- 7316994
- 510(k) numbers
- not on file
- PMA numbers
- ["P030053"]
- Product code
- FTR
- Firm FEI
- 1000118360
- Firm city
- Irving
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28