Mentor Texas, LP.: Medical Device Recall in 2015 - (Recall #: Z-0964-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: December 11, 2014

Date Posted: January 21, 2015

Recall Number: Z-0964-2015

Event ID: 70042

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.

Status: Terminated

Product Quantity: 45 units

Code Information:

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.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated