FDAFDA · Food and drugs·Recall number Z-2591-2014
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.
Published September 10, 2014 · Recall initiated: July 2, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The device labeling is stamped with 330cc and the device is actually 380cc device.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Mentor Texas, LP.
- Distributor
- U.S Nationwide Distribution in the states of Michigan, Maryland, Texas, New Jersey, Indiana, Nevada, Florida, California, New York, Tennessee, Pennsylvania, and Colorado.
- Lot
- Part Number (PN) 351-3380SZ Lot Number 6830722
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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