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Mentor Texas, LP. recalls EN MENTOR Round High Profile Single Use Saline Breast Implant Sizer Single Use Saline Breast Implant Sizer REF 351-338
Recalled September 10, 2014 · FDA recall Z-2591-2014 · Mentor Texas
Hazard
The device labeling is stamped with 330cc and the device is actually 380cc device. · FDA Class II
Units
34 units
Sold at
U.S Nationwide Distribution in the states of Michigan, Maryland, Texas, New Jersey, Indiana, Nevada, Florida, California, New York, Tennessee, Pennsylvania, and Colorado.
Description
The device labeling is stamped with 330cc and the device is actually 380cc device.
Product
EN MENTOR Round High Profile Single Use Saline Breast Implant Sizer Single Use Saline Breast Implant Sizer REF 351-3380SZ 380 cc LOT 6830722. Product Usage: This product is indicated for single use for temporary insertion intraoperatively to evaluate the volume of the breast implant to be implanted.
Manufacturer(s)
Mentor Texas, LP.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →