Reported Jan 21, 2015 · Terminated

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

Mentor Texas, LP.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Mentor Texas, LP. · 3041 Skyway Cir N · Irving, TX · 75038-3500

Is this the product you have?

  • MENTOR MemoryGel Resterilizable Gel Sizer Moderate Plus Profile STERILE. Breast prosthesis sizer.
Lot codes and dates
  • 63 of 63 codes

    • 6790747-030
    • 6684051-002
    • 6685063-013
    • 6728126-044
    • 6822437-031
    • 6685063-011
    • 6728128-035
    • 6702298-031
    • 6838011-018
    • 6733863-003
    • 6733863-017
    • 6701421-023
    • 6696938-022
    • 6824389-004
    • 6719893-016
    • 6687714-031
    • 6834854-016
    • 6839585-001
    • 6849927-019
    • 6675404-028
    • 6684051-031
    • 6803156-029
    • 6838011-020
    • 6825406-014
    • 6751554-012
    • 6741590-026
    • 6830995-006
    • 6721250-014
    • 6694754-031
    • 6707932-006
    • 6789276-002
    • 6790619-029
    • 6821980-010
    • 6853040-025
    • 6691833-020
    • 6715539-004
    • 6836766-012
    • 6683549-030
    • 6703183-005
    • 6789532-021
    • 6789191-001
    • 6848592-012
    • 6790747-028
    • 6833028-030
    • 6723961-006
    • 6716622-011
    • 6742458-008
    • 6684051-026
    • 6685067-008
    • 6703784-036
    • 6748082-029
    • 6748820-019
    • 6822436-028
    • 6827017-004
    • 6829287-016
    • 6834856-021
    • 6825200-001
    • 6701421-034
    • 6716223-011
    • 6794993-017
Amount recalled
45 units

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jan 4, 2016 · Data as of Sep 19, 5:32 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.