Health product recall

MENTOR ® Saline Breast Implants

Brand(s)
Last updated

Summary

Product
MENTOR ® Saline Breast Implants
Issue
Medical devices - Premature failure
What to do

Contact the manufacturer if you require additional information.

Affected products

Affected Products

Lot or serial number

Model or catalog number

SALINE-FILLED MAMMARY PROSTHESES WITH DIAPHRAGM VALVE

More than 10 numbers, contact manufacturer.

350-1610
350-1620
350-1625
350-1630
350-1635
350-1640
350-1645
350-1650
350-1655
350-1660

SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST IMPLANT W/DIAPHRAGM VALVE

More than 10 numbers, contact manufacturer.

350-2200
350-2225
350-2250
350-2275
350-2300
350-2325
350-2350
350-2375
350-2400
350-2425

SMOOTH ROUND HIGH PROFILE SALINE-FILLED MAMMARY PROSTHESIS

More than 10 numbers, contact manufacturer.

350-3210
350-3230
350-3250
350-3270
350-3290
350-3310
350-3330
350-3380
350-3420
350-3460

Issue

A small number of implants may have a potential weakened shell on the patch area which may result in premature deflation.

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General and plastic surgery
Companies

Mentor

3041 Skyway Circle North

Irving

75038

Texas

UNITED STATES

Published by
Health Canada
Audience
General public
Hospitals
Manufacturers
Recall class
Type II
Identification number
RA-63975

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