Recall Z-2591-2014— Mentor Texas, LP.
Class II · Terminated
Class II FDA medical device recall by Mentor Texas, LP., initiated 2014-07-02, terminated 2015-04-06. It names one FDA 510(k) clearance: K010709. 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.. Reason: The device labeling is stamped with 330cc and the device is actually 380cc device..
- Recalling firm
- Mentor Texas, LP.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-07-02
- Terminated
- 2015-04-06
- Firm location
- Irving, TX, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.