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U.S. Department of Health and Human Services

Class 3 Device Recall Shellgel

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  Class 3 Device Recall Shellgel see related information
Date Initiated by Firm October 08, 2003
Date Posted November 13, 2003
Recall Status1 Terminated 3 on August 09, 2004
Recall Number Z-0108-04
Recall Event ID 27457
PMA Number P0000046 
Product Classification Aid, Surgical, Viscoelastic - Product Code LZP
Product ShellGell Sodium Hyaluronate 0.8mL Syringe,
12 mg/mL. Sterile. Rx. For intraocular use.

Product Number: 1000
Distributed by Cytosol Opthalmics, Inc., Lenick, NC
Code Information Lot Number: B020122B
Recalling Firm/
Manufacturer		 Anika Therapeutics
240 West Cummings Park
Woburn MA 01801
For Additional Information Contact Julie Broderick
781-932-6616 Ext. 107
Manufacturer Reason
for Recall		 Stability failure at the 20 month for viscosity specification
FDA Determined
Cause 2		 Other
Action Anika Therapeutics issued notification on 10/8/2003 by fax and FedEx to three Distributors. Distributors were requested to subrecall to their customers.
Quantity in Commerce 10,100 units
Distribution CA, MO, NC,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.
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