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
FDA Recall Z-1080-2007 · Posted 2007-07-24
Recalling FirmSynovis Surgical Inovation Div. of
Recall StatusTerminated
Product CodeGDF
Date Initiated2007-06-19
Date Terminated2012-05-08
Product Quantity2 boxes (8 units)
Reason for Recall
There is a potential for the pouch to become damaged during shipping, compromising the sterility of the device inside.
Firm 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.
Root Cause
Other
Distribution Pattern
Nationwide.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.