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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