Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Mentor Smooth Round SPECTRUM Post- Operatively Adjustable Saline Breast Implant Recalled by Mentor Texas, LP. Due to Missing Dome Pack accessory.

Date: March 27, 2017
Company: Mentor Texas, LP.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Mentor Texas, LP. directly.

Affected Products

Mentor Smooth Round SPECTRUM Post- Operatively Adjustable Saline Breast Implant, Product Code: 350-1490, UDI/GTIN: 00081317002048

Quantity: 28 units

Why Was This Recalled?

Missing Dome Pack accessory.

Where Was This Sold?

This product was distributed to 9 states: CA, CT, IL, IN, MI, NY, NC, OH, OK

Affected (9 states)Not affected

About Mentor Texas, LP.

Mentor Texas, LP. has 9 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report