Recall Z-0964-2015— Mentor Texas, LP.

Name: FDA recall Z-0964-2015
Creator: U.S. Food and Drug Administration
Published: 2014-12-11

Class II · Terminated

Class II FDA medical device recall by Mentor Texas, LP., initiated 2014-12-11, terminated 2016-01-04. It names one FDA 510(k) clearance: K062421. Product: MENTOR MemoryGel Resterilizable Gel Sizer Moderate Plus Profile STERILE. Breast prosthesis sizer.. Reason: The IFU provided in the affected units of the MENTOR MemoryGel Resterilizable Sizer is incorrect. Those units include the IFU for the MENTOR MemoryShape Resterilizable Sizer..

Recalling firm: Mentor Texas, LP.
Classification: Class II
Status: Terminated
Initiated: 2014-12-11
Terminated: 2016-01-04
Firm location: Irving, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K062421 — MENTOR RESTERILIZABLE GEL BREAST IMPLANT SIZERMentor Corporation·cleared 2006-10-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

MENTOR MemoryGel Resterilizable Gel Sizer Moderate Plus Profile STERILE. Breast prosthesis sizer.

Reason for recall

The IFU provided in the affected units of the MENTOR MemoryGel Resterilizable Sizer is incorrect. Those units include the IFU for the MENTOR MemoryShape Resterilizable Sizer.

Data sourced from openFDA. This site is unofficial and independent of the FDA.