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U.S. Department of Health and Human Services

Class 2 Device Recall Allergan SeriScaffold Surgical Scaffold

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 Class 2 Recall
Allergan SeriScaffold Surgical Scaffold
see related information
Date Posted February 07, 2013
Recall Status1 Terminated on July 29, 2013
Recall Number Z-0794-2013
Recall Event ID 64069
Premarket Notification
510(K) Number
K080442 
Product Classification Mesh, Surgical, Polymeric - Product Code FTL
Product SeriScaffold Surgical Scaffold Product Number: SCF10X25AGEN. Surgical mesh for use in open or laparoscopic procedures.
Code Information Lot Numbers: P2012040901 (US) P2011080101B and P2011090901A (Outside the US)
Recalling Firm/
Manufacturer
Allergen Medical
200 Boston Avenue
Medford, Massachusetts 02155
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
Product is dual packaged in an inner and outer pouch, the outer pouch seal may be compromised and sterility may not be assured
FDA Determined
Cause 2
PRODUCTION CONTROLS: Packaging Process Control
Action Allergan sent an "URGENT MEDICAL DEVICE RECALL" letter dated January 8, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers are requested to quarantine and return any unused devices in inventory . In addition, customers are asked to complete and return the acknowledgement form. Customers with questions should contact Allergan at 781-658-2800, Mon- Fri, 9 a.m. to 5 p.m. EST.
Quantity in Commerce 225 units (US) and 81 (Outside US)
Distribution Worldwide Distribution-USA including the states of CA, FL, GA, MI, MN, NJ, NY, OH, OR, RI, TX, VA, and WA, and the countries of Germany, Spain, and UK.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FTL and Original Applicant = SERICA TECHNOLOGIES, INC.
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