MENTOR MemoryGel Resterilizable Gel Sizer Moderate Plus Profile STERILE. Breast prosthesis sizer.
FDA Recall Z-0964-2015 · Posted 2015-01-13
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Recalling FirmMentor Texas, LP.
Recall StatusTerminated
Product CodeMRD
Date Initiated2014-12-11
Date Terminated2016-01-04
Product Quantity45 units
Reason for Recall
The IFU provided in the affected units of the MENTOR MemoryGel Resterilizable Sizer is incorrect. Those units include the IFU for the MENTOR MemoryShape Resterilizable Sizer.
Firm Action
Mentor sent an Important Labeling Correction letter dated December 19, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
The firm plans to follow-up with sales representative visits. The recall letter notifies the customer of the issue, but does not instruct them to return the product. Should the customer chose to return the product, all returned product will be tagged to denote no further distribution. The recalled units under firm control have been placed on hold in the inventory system.
If you have any questions related to this notice, please contact your local Mentor Sales Representative, or Mentor Customer Service at 1-800-235-5731.
Root Cause
Employee error
Distribution Pattern
US Distribution to the states of : MA, WV, NY, FL, ME, NC, TX, IL, KS, TN, NJ, PA, CA, OR, WI, GA, and WA
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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