Z-2591-2014 Class II Terminated
FDA device recall Z-2591-2014 was initiated by Mentor Texas, LP. on July 2, 2014 and is designated Class II. Reason for recall: The device labeling is stamped with 330cc and the device is actually 380cc device. The recall status is terminated (terminated April 6, 2015). Affected quantity: 34 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 10, 2014
- Initiation Date
- July 2, 2014
- Termination Date
- April 6, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 34 units
Product Description
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.
Reason for Recall
The device labeling is stamped with 330cc and the device is actually 380cc device.
Distribution Pattern
U.S Nationwide Distribution in the states of Michigan, Maryland, Texas, New Jersey, Indiana, Nevada, Florida, California, New York, Tennessee, Pennsylvania, and Colorado.
Code Information
Part Number (PN) 351-3380SZ Lot Number 6830722