Mentor Saline Breast Implant Sizer Recalled for Volume Labeling Error
Mentor Texas, LP. is recalling 34 units of saline breast implant sizers because the device labeling states 330cc while the actual device volume is 380cc.
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: The recall is classified as FDA Class II, and the hazard is a labeling error (330cc vs 380cc) without reported injuries or illnesses, fitting the criteria for moderate severity.
Plain-English summary
Mentor Texas, LP. is recalling 34 units of EN MENTOR Round High Profile Single Use Saline Breast Implant Sizers. The recall involves devices with Part Number 351-3380SZ and Lot Number 6830722. These products are indicated for single use for temporary insertion intraoperatively to evaluate the volume of the breast implant to be implanted.
The reason for the recall is a labeling discrepancy: the device labeling is stamped with 330cc, but the device is actually a 380cc device. This mislabeling could lead to incorrect volume evaluation during surgery.
The affected units were distributed nationwide in the United States, specifically in the states of Michigan, Maryland, Texas, New Jersey, Indiana, Nevada, Florida, California, New York, Tennessee, Pennsylvania, and Colorado. Healthcare providers and facilities that may have received these specific units should verify their inventory against the provided lot and part numbers and contact the manufacturer for further instructions.
The recalled product
- Product
- EN MENTOR Round High Profile Single Use Saline Breast Implant Sizer Single Use Saline Breast Implant Sizer REF 351-3380SZ 380 cc LOT 6830722. Product Usage: This product is indicated for single use for temporary insertion intraoperatively to evaluate the volume of the…
- Manufacturer
- Mentor Texas, LP.
- Hazard
- Affected units
- 34
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)
- Part Number (PN) 351-3380SZ Lot Number 6830722
Distribution
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