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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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.
- Category
- Medical Device — Breast Implant
- Hazard
- 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
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