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U.S. Department of Health and Human Services

Class 3 Device Recall Storz

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 Class 3 Device Recall Storzsee related information
Date Initiated by FirmOctober 08, 2003
Date PostedNovember 13, 2003
Recall Status1 Terminated 3 on August 09, 2004
Recall NumberZ-0112-04
Recall Event ID 27457
PMA NumberP810025 
Product Classification Aid, Surgical, Viscoelastic - Product Code LZP
ProductHialuronato Sodico Sodium Hyaluronate 12 mg/mL 1X0.8 mL Sterile. RX. For Intraocular use. Product Number: 014-180A
Code Information Lot Number: B020122H
Recalling Firm/
Manufacturer		 Anika Therapeutics
240 West Cummings Park
Woburn MA 01801
For Additional Information ContactJulie Broderick
781-932-6616 Ext. 107
Manufacturer Reason
for Recall		Stability failure at the 20 month for viscosity specification
FDA Determined
Cause 2		Other
ActionAnika Therapeutics issued notification on 10/8/2003 by fax and FedEx to three Distributors. Distributors were requested to subrecall to their customers.
Quantity in Commerce2901 units
DistributionCA, MO, NC,VA
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.
PMA DatabasePMAs with Product Code = LZP
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