Mentor Breast Implant Recall Due to Missing Dome Pack Accessory
Mentor Texas, LP. is recalling 28 units of Mentor Smooth Round SPECTRUM Post-Operatively Adjustable Saline Breast Implants because the Dome Pack accessory is missing.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is for a missing accessory (Dome Pack) with no reported injuries or illnesses, fitting the criteria for packaging or documentation issues.
Plain-English summary
Mentor Texas, LP. is recalling 28 units of Mentor Smooth Round SPECTRUM Post-Operatively Adjustable Saline Breast Implants (Product Code: 350-1490, UDI/GTIN: 00081317002048). The recall is due to a missing Dome Pack accessory.
The affected products are identified by Lot Number 7377332. These units were distributed in the United States to the states of Michigan, California, Connecticut, Illinois, Indiana, New York, North Carolina, Ohio, and Oklahoma.
Consumers and healthcare providers with these specific implants should contact Mentor Texas, LP. for further instructions regarding the missing accessory.
The recalled product
- Product
- Mentor Smooth Round SPECTRUM Post- Operatively Adjustable Saline Breast Implant, Product Code: 350-1490, UDI/GTIN: 00081317002048
- Manufacturer
- Mentor Texas, LP.
- Category
- Medical Device — Breast Implant
- Hazard
- Affected units
- 28
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)
- Lot Number: 7377332
Distribution
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