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U.S. Department of Health and Human Services

Class 2 Device Recall Natrelle CUI Tissue Expander

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  Class 2 Device Recall Natrelle CUI Tissue Expander see related information
Date Initiated by Firm June 18, 2015
Date Posted July 18, 2015
Recall Status1 Terminated 3 on December 16, 2015
Recall Number Z-2104-2015
Recall Event ID 71498
510(K)Number K865056  
Product Classification Expander, skin, inflatable - Product Code LCJ
Product Natrelle CUI Series Tissue Expanders.

Product Usage:
Natrelle CUI Series Tissue Expander has been designed for temporary implantation to develop a skin flap. The device is used for reconstructive correction of a defect or to provide cover for a prosthetic implant. The CUI Tissue Expander consists of a silicone elastomer envelope and a remote injection port.
Code Information Serial No. (Lot No.) VE7507 (5F075-OEM), VE9273 (6H009-OEM), VF4561 (09H024-OEM), VF5340 (10A115-OEM), VE9272 (6H009-OEM), VF3627 (09E231-OEM), VE9117 (6F158-OEM), VF1201 (7K195-OEM), VF5396 (10A182-OEM), VF5341 (10A115-OEM), VF4923 (09J052-OEM), VF1420 (7L085-OEM), VF1327(7L043-OEM), VE7508 (5F075-OEM), VF1427 (7L085-OEM), VE9274 (6H009-OEM).            
Recalling Firm/
Allergan Inc
2525 Dupont Dr
Irvine CA 92612-1531
For Additional Information Contact
Manufacturer Reason
for Recall
Allergan is recalling the NATRELLE 133 and CUI Series Tissue Expanders because the products shipped were beyond the shelf life.
FDA Determined
Cause 2
Incorrect or no expiration date
Action A recall letter will be sent on 6/18/15 to all customers who received the NATRELLE 133 and CUI series tissue expanders. 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.
Quantity in Commerce 23 units total (16 units in US)
Distribution US in the state of Canada
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 = LCJ and Original Applicant = COX-UPHUFF INTL.