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U.S. Department of Health and Human Services

Class 2 Device Recall MENTOR MemoryGel Sizer

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 Class 2 Device Recall MENTOR MemoryGel Sizersee related information
Date Initiated by FirmDecember 11, 2014
Date PostedJanuary 13, 2015
Recall Status1 Terminated 3 on January 04, 2016
Recall NumberZ-0964-2015
Recall Event ID 70042
510(K)NumberK062421 
Product Classification Sizer, mammary, breast implant volume - Product Code MRD
ProductMENTOR MemoryGel Resterilizable Gel Sizer Moderate Plus Profile STERILE. Breast prosthesis sizer.
Code Information 6790747-030, 6684051-002, 6685063-013, 6728126-044, 6822437-031, 6685063-011, 6728128-035, 6702298-031, 6838011-018, 6733863-003, 6733863-017, 6701421-023, 6696938-022, 6824389-004, 6719893-016, 6687714-031, 6834854-016, 6839585-001, 6849927-019, 6675404-028, 6684051-031, 6803156-029, 6838011-020, 6825406-014, 6751554-012, 6741590-026, 6830995-006, 6721250-014, 6694754-031, 6707932-006, 6789276-002, 6790619-029, 6821980-010, 6853040-025, 6691833-020, 6715539-004, 6836766-012, 6683549-030, 6703183-005, 6789532-021, 6789191-001, 6848592-012, 6790747-028, 6833028-030, 6723961-006, 6716622-011, 6742458-008, 6684051-026, 6685067-008, 6703784-036, 6748082-029, 6748820-019, 6822436-028, 6827017-004, 6829287-016, 6834856-021, 6825200-001, 6701421-034, 6716223-011, 6794993-017, 6723958-007, 6723958-011, 6723957-042.
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 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.
FDA Determined
Cause 2		Employee error
ActionMentor 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.
Quantity in Commerce45 units
DistributionUS Distribution to the states of : MA, WV, NY, FL, ME, NC, TX, IL, KS, TN, NJ, PA, CA, OR, WI, GA, and WA
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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