FDA-Device2015-01-21Class II
MENTOR MemoryGel Resterilizable Gel Sizer Moderate Plus Profile STERILE. Breast prosthesis sizer.
Mentor Texas, LP.
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.
Sold states
US Distribution to the states of : MA, WV, NY, FL, ME, NC, TX, IL, KS, TN, NJ, PA, CA, OR, WI, GA, and WA
Affected count
45 units
Manufactured in
3041 Skyway Cir N, Irving, TX, United States
Products
MENTOR MemoryGel Resterilizable Gel Sizer Moderate Plus Profile STERILE. Breast prosthesis sizer.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0964-2015Don't want to check this manually?
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