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Class 2 Device Recall 4Closure Surgical Fascia |
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Date Initiated by Firm |
June 19, 2007 |
Date Posted |
July 24, 2007 |
Recall Status1 |
Terminated 3 on May 08, 2012 |
Recall Number |
Z-1085-2007 |
Recall Event ID |
38261 |
Product Classification |
surgical suture - Product Code GDF
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Product |
Allez Medical Applications, Inc. 4Closure Surgical Fascia Closure System , Catalog ref. 4S. Sterile, One Time Use, Contents 4 sets 1- suture passer instrument. 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 |
5729939-574724 |
Recalling Firm/ Manufacturer |
Synovis Surgical Inovation Div. of 2575 University Ave W Saint Paul MN 55114-1073
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For Additional Information Contact |
651-603-3700
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Manufacturer Reason for Recall |
There is a potential for the pouch to become damaged during shipping, compromising the sterility of the device inside.
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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 |
1box (4 untis) |
Distribution |
Nationwide. |
Total Product Life Cycle |
TPLC Device Report
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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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