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Terminated

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

FDA Recall Z-1085-2007 · Posted 2007-07-24

Recalling FirmSynovis Surgical Inovation Div. of
Recall StatusTerminated
Product CodeGDF
Date Initiated2007-06-19
Date Terminated2012-05-08
Product Quantity1box (4 untis)

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.

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