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Mentor Texas, LP. recalls MENTOR MemoryGel Resterilizable Gel Sizer Moderate Plus Profile STERILE. Breast prosthesis sizer.
Recalled January 21, 2015 · FDA recall Z-0964-2015 · Mentor Texas
Hazard
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. · FDA Class II
Units
45 units
Sold at
US Distribution to the states of : MA, WV, NY, FL, ME, NC, TX, IL, KS, TN, NJ, PA, CA, OR, WI, GA, and WA
Description
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
MENTOR MemoryGel Resterilizable Gel Sizer Moderate Plus Profile STERILE. Breast prosthesis sizer.
Manufacturer(s)
Mentor Texas, LP.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →