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U.S. Department of Health and Human Services

Class 2 Device Recall 4Closure Surgical Fascia

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  Class 2 Device Recall 4Closure Surgical Fascia see related information
Date Initiated by Firm June 19, 2007
Date Posted July 24, 2007
Recall Status1 Terminated 3 on May 08, 2012
Recall Number Z-1080-2007
Recall Event ID 38261
Product Classification surgical suture - Product Code GDF
Product Allez Medical Applications, Inc. 4Closure Surgical Fascia Closure System , Catalog ref. 4-10GPS. Sterile, One Time Use, Contents 4 sets 1- suture passer instrument, 1-guide rod, 10 mm, 250 mm long.
Distributed by Aliez Medical Applications, Inc., Santa Ana, CA 92707. Synovis over labels the "Distributed by....", For Customer Service Contact: Synovis Surgical Innovations 2575 University Ave W., St. Paul, MN 55114-1024
Code Information 5729973-575783
Recalling Firm/
Manufacturer		 Synovis Surgical Inovation Div. of
2575 University Ave W
Saint Paul MN 55114-1073
For Additional Information Contact
651-603-3700
Manufacturer Reason
for Recall		 There is a potential for the pouch to become damaged during shipping, compromising the sterility of the device inside.
FDA Determined
Cause 2		 Other
Action Consignees were sent a letter on June 19, 2007. The letter identified the product and problem. The letter also included a form for inventory purposes which is to be completed and faxed to Synovis.
Quantity in Commerce 2 boxes (8 units)
Distribution Nationwide.
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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