The Recall Desk
LowFDA (Devices)·Z-2070-2017·Announced 2017-05-17

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.

What this means for you

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

Distributed in 9 states:

Related recalls

Same manufacturer · Mentor Texas, LP.

See all →