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U.S. Department of Health and Human Services

Class 2 Device Recall Natrelle

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  Class 2 Device Recall Natrelle see related information
Date Initiated by Firm June 08, 2015
Date Posted July 07, 2015
Recall Status1 Terminated 3 on December 16, 2015
Recall Number Z-1988-2015
Recall Event ID 71428
510(K)Number K831566  
Product Classification Sizer, mammary, breast implant volume - Product Code MRD
Product Natrelle Re-sterilizable Breast Implant Sizer, Size: 410 cc, Style No. MSZFX410.

The product is packaged in a thermoformed tray (double sterile barrier) and enclosed in a labeled carton.
Code Information Lot # Serial # Style #: 1703043, 14124459, MSZFX410; 1708499, 14164655, MSZFX410; 1801072, 14768661, MSZFX410; 1819375, 14905528, MSZFX410; 1819377, 14911183, MSZFX410; 1819377, 14911197, MSZFX410; 1819377, 14911180, MSZFX410; 1819378, 14907262, MSZFX410; 1819378, 14907266, MSZFX410.
Recalling Firm/
Manufacturer		 Allergan Inc
2525 Dupont Dr
Irvine CA 92612-1531
For Additional Information Contact
714-246-4388
Manufacturer Reason
for Recall		 Allergan is recalling the NATRELLE 410cc Re-Sterilizable Breast Implant Sizer because the expired product was shipped to the user level.
FDA Determined
Cause 2		 Error in labeling
Action A recall letter dated 6/8/15 was sent to all customers who received the NATRELLE 410 cc Re-Sterilizable Breast Implant Sizer. The letter provides the problem identified and the action to be taken. Customers are instructed to contact GENCO Pharmaceutical Services if the recall actions on the recall letter are unclear. For product returns, customers are instructed to contact GENCO at (877) 319-8966, 7am to 5pm CST. Customers with credit/reimbursements are instructed to contact Allergan at (800) 811-4148, 7am to 5pm PST. Customers with medical inquiries are instructed to contact (800) 433-8871, option 2, 8am-5pm, PST. Customers with adverse events/product complaints are instructed to call (800) 624-4261, option 3, 8am-5pm CST. On June 12, 2015, Actavis sent follow up letters to customers to include one additional serial number.
Quantity in Commerce 9 units
Distribution CA, IN, MO, NJ, VA
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = MRD and Original Applicant = COX-UPHUFF INTL.
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