The Recall Desk
ModerateFDA (Devices)·Z-2326-2016·Announced 2016-08-10

Mentor MemoryGel Breast Implant Recall Due to Missing Date Labels

Mentor Texas, LP is recalling 35 units of 300cc MemoryGel Breast Implants because the boxes were labeled with null manufacturing and expiration dates.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is classified as Moderate because it involves a minor labeling error (missing dates) on a medical device, which fits the rubric criteria for documentation issues without reported injuries or immediate physical hazards.

Plain-English summary

Mentor Texas, LP is recalling 35 units of Mentor MemoryGel Breast Implants. The specific product involved is the 300cc implant, which is indicated for females for breast augmentation and breast reconstruction.

The recall was initiated because the boxes for these implants were labeled with null manufacturing and expiration dates. This labeling error prevents verification of the product's shelf life and manufacturing timeline.

The affected units were distributed in the states of New York, Wisconsin, California, Texas, Colorado, North Carolina, New Jersey, Ohio, Tennessee, Rhode Island, and Illinois. The product code is 7316994. Consumers and healthcare providers should check their inventory for these specific units and contact the manufacturer for instructions on removal or replacement.

The recalled product

Product
Mentor MemoryGel Breast Implant; Indicated for females for breast augmentation and breast reconstruction.
Manufacturer
Mentor Texas, LP.
Affected units
35

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • 7316994

Distribution

Distributed in 11 states: