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.
FDA Recall Z-2591-2014 · Posted 2014-09-04
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Recalling FirmMentor Texas, LP.
Recall StatusTerminated
Product CodeMRD
Date Initiated2014-07-02
Date Terminated2015-04-06
Product Quantity34 units
Reason for Recall
The device labeling is stamped with 330cc and the device is actually 380cc device.
Firm Action
Mentor 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.
Root Cause
Error in labeling
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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