CLASS II Device recall · Reported 21 Jan 2015 · FDA Enforcement Report

Mentor MemoryGel Resterilizable Gel Sizer Moderate Plus recalled

Mentor Texas is recalling Mentor MemoryGel Resterilizable Gel Sizer Moderate Plus Profile Sterile, distributed in 17 states. The recall was initiated on 11 Dec 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes6790747-030, 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, 6723958-007, 6723958-011, 6723957-042.

Quantity recalled45 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0964-2015
FDA event ID: 70042
Recalling firm: Mentor Texas, Irving, TX
Classification: Class II
Status: Terminated
Recall initiated: 11 Dec 2014
FDA classified: 13 Jan 2015
Reported: 21 Jan 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

11 Dec 2014	Recall initiated by company
13 Jan 2015	Classified by FDA	+33 days
21 Jan 2015	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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

Where it was distributed

US Distribution to the states of : MA, WV, NY, FL, ME, NC, TX, IL, KS, TN, NJ, PA, CA, OR, WI, GA, and WA

California Florida Georgia Illinois Kansas Massachusetts Maine North Carolina New Jersey New York Oregon Pennsylvania Tennessee Texas Washington Wisconsin West Virginia

Questions about this recall

Why was it 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.

Which lots are affected?

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, 6723958-007, 6723958-011, 6723957-042.

Where was it sold?

US Distribution to the states of : MA, WV, NY, FL, ME, NC, TX, IL, KS, TN, NJ, PA, CA, OR, WI, GA, and WA

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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