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U.S. Department of Health and Human Services

Class 2 Device Recall MENTOR Sterile Saline Mammary Volume Sizer

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 Class 2 Device Recall MENTOR Sterile Saline Mammary Volume Sizersee related information
Date Initiated by FirmJuly 02, 2014
Date PostedSeptember 04, 2014
Recall Status1 Terminated 3 on April 06, 2015
Recall NumberZ-2591-2014
Recall Event ID 69022
510(K)NumberK010709 
Product Classification Sizer, mammary, breast implant volume - Product Code MRD
ProductEN 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.
Code Information Part Number (PN) 351-3380SZ Lot Number 6830722
Recalling Firm/
Manufacturer		 Mentor Texas, LP.
3041 Skyway Cir N
Irving TX 75038-3500
For Additional Information Contact
972-257-4788
Manufacturer Reason
for Recall		The device labeling is stamped with 330cc and the device is actually 380cc device.
FDA Determined
Cause 2		Error in labeling
ActionMentor sent an Important Customer Notification letter dated July 17, 2014 to all affected customers and follow-up with a visit by the local sales representative. The letter identified the affected product, problem and actions to be taken. Customers were instructed to immediately identify all unsused product from lot list provided and maintain a copy of this notice with the affected product. For question contact your local Sales Representative or Mentor Customer Service at 1-800-235-5731.
Quantity in Commerce34 units
DistributionU.S Nationwide Distribution in the states of Michigan, Maryland, Texas, New Jersey, Indiana, Nevada, Florida, California, New York, Tennessee, Pennsylvania, and Colorado.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = MRD
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